83 FR 26465 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 110 (June 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26465-26475 | |
| FR Document | 2018-12222 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26465-26475] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12222] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2004-N-0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 049'' (Recognition List Number: 049), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: These modifications to the list of recognized standards are applicable June 7, 2018. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 049. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the [[Page 26466]] ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 049 is available on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 049 modifications and other standards related information. Submit written requests for a single hard copy of the document entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 049'' to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self- addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144. FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In the Federal Register notice of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. The guidance was updated in September 2007 and is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077274.htm. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains hypertext markup language (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. II. Modifications to the List of Recognized Standards, Recognition List Number: 049 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term ``Recognition List Number: 049'' to identify the current modifications. In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--Modifications to the List of Recognized Standards ---------------------------------------------------------------------------------------------------------------- Replacement Old recognition No. recognition Title of standard \1\ Change No. ---------------------------------------------------------------------------------------------------------------- A. Anesthesiology ---------------------------------------------------------------------------------------------------------------- 1-86............................. .............. ISO 8185 Third edition 2008-06- Withdrawn. See 1-138. 15 (Corrected version), Respiratory tract humidifiers for medical use--Particular requirements for respiratory humidification systems. 1-95............................. .............. ISO 5366-3 Second edition 2001- Withdrawn. See 1-117. 08-15 Anaesthetic and Respiratory Equipment-- Tracheostomy Tubes--Part 3: Paediatric Tracheostomy Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)]. 1-107............................ .............. ANSI/AAMI/ISO 5356-1:2004 Transferred. See 1-62. Anaesthetic and respiratory equipment--Conical connectors-- Part 1: Cones and sockets. 1-109............................ .............. ANSI/AAMI/ISO 5362:2006 Transferred. See 1-75. Anaesthetic reservoir bags. 1-121............................ 1-129 ISO 5359 Fourth edition 2014-10- Withdrawn and replaced with 01 Anaesthetic and respiratory newer version including equipment--Low-pressure hose amendment. assemblies for use with medical gases [Including AMENDMENT 1 (2017)]. 1-128............................ 1-130 ISO 18082 First edition 2014-06- Withdrawn and replaced with 15 Anaesthetic and respiratory newer version including equipment--Dimensions of amendment. noninterchangeable screw- threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-118............................ .............. ANSI/AAMI/ISO 10993-11:2006/ Transferred. See 2-176. (R)2010 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity. 2-120............................ .............. ANSI/AAMI/ISO 10993-6:2007/ Withdrawn. (R)2014 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation. 2-153............................ .............. ANSI/AAMI/ISO 10993-5:2009/ Transferred. See 2-245. (R)2014 Biological evaluation of medical devices--Part 5: Tests for in vitro cytotoxicity. [[Page 26467]] 2-156............................ .............. ANSI/AAMI/ISO 10993-1:2009/ Transferred. See 2-220. (R)2013 Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. 2-163............................ .............. ANSI/AAMI/ISO 10993-9:2009/ Transferred. See 2-168. (R)2014 Biological evaluation of medical devices--Part 9: Framework for identification and quantification of potential degradation products. 2-165............................ .............. ANSI/AAMI/ISO 10993-14:2001/(R) Transferred. See 2-170. 2011 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products form ceramics. 2-171............................ 2-249 ISO 10993-16 Third edition 2017- Withdrawn and replaced with 05 Biological evaluation of newer version. medical devices--Part 16: Toxicokinetic study design for degradation products and leachables. 2-172............................ .............. ANSI/AAMI/TIR 10993-19:2006 Transferred. See 2-167. Biological evaluation of medical devices--Part 19: Physicochemical, morphological, and topographical characterization of materials. 2-173............................ .............. ANSI/AAMI/ISO 10993-10:2010/ Transferred. See 2-174. (R)2014 Biological evaluation of medical devices--Part 10: Tests for irritation and skin sensitization. 2-180............................ .............. ANSI/AAMI/ISO 10993-16:2010/ Withdrawn. (R)2014 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables from medical devices. 2-181............................ .............. ANSI/AAMI/ISO 14155:2011 Transferred. See 2-205. Clinical investigation of medical devices for human subjects--Good clinical practice [Including: Technical Corrigendum 1 (2011)]. 2-190............................ .............. ANSI/AAMI/ISO 10993-13:2010/ Transferred. See 2-169. (R)2014 Biological evaluation of medical devices--Part 13: Identification and quantification of degradation products from polymeric medical devices. 2-198............................ .............. ANSI/AAMI/ISO 10993-12:2012 Transferred. See 2-191. Biological evaluation of medical devices--Part 12: Sample preparation and reference materials. 2-207............................ 2-250 ASTM F756-17 Standard Practice Withdrawn and replaced with for Assessment of Hemolytic newer version. Properties of Materials. 2-221............................ .............. ANSI/AAMI/ISO 10993-2:2006 Transferred. See 2-222. (R2014) Biological evaluation of medical devices--Part 2: Animal welfare requirements. 2-226............................ .............. ANSI/AAMI/ISO 10993-3:2014 Transferred. See 2-228. Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. 2-229............................ 2-251 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with Reactivity Test, In Vitro-- newer version. Direct Contact Test. 2-230............................ 2-252 USP 40-NF35:2017 <87> Biological Withdrawn and replaced with Reactivity Test, In Vitro-- newer version. Elution Test. 2-231............................ 2-253 USP 40-NF35:2017 <88> Biological Withdrawn and replaced with Reactivity Tests, In Vivo. newer version. 2-232............................ 2-254 USP 40-NF35:2017 <151> Pyrogen Withdrawn and replaced with Test (USP Rabbit Test). newer version. Extent of Recognition. 2-234............................ .............. ANSI/AAMI/ISO 10993-4:2002/(R) Withdrawn. 2013 & A1:2006/(R)2013 Biological evaluation of medical devices--Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)]. 2-236............................ .............. ANSI/AAMI/ISO 10993-17:2002(R) Transferred. See 2-237. 2012 Biological evaluation of medical devices--Part 17: Establishment of allowable limits for leachable substances. 2-239............................ .............. ANSI/AAMI/ISO TIR 10993-20:2006 Transferred. See 2-240. Biological Evaluation of Medical Devices--Part 20: Principles and methods for immunotoxicology testing of medical devices. 2-242............................ .............. ANSI/AAMI/ISO TIR 37137:2014 Transferred. See 2-241. Cardiovascular biological evaluation of medical devices-- Guidance for absorbable implants. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-80............................. .............. ANSI/AAMI/ISO 81060-1:2007/ Transferred. See 3-96. (R)2013 Non-invasive sphygmomanometers--Part 1: Requirements and test methods for non-automated measurement type. 3-83............................. .............. ANSI/AAMI/ISO 14708-5:2010 Transferred. See 3-92. Implants for surgery--Active implantable medical devices-- Part 5: Circulatory support devices. 3-101............................ .............. ANSI/AAMI/IEC 60601-2-27:2011 Transferred. See 3-126. Medical electrical equipment-- Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment. 3-106............................ .............. ANSI/AAMI/IEC 60601-2-25:2011/ Transferred. See 3-105. (R)2016 Medical electrical equipment--Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. [[Page 26468]] 3-109............................ .............. ANSI/AAMI/ISO 27186:2010 Active Transferred. See 3-89. implantable medical devices-- Four-pole connector system for implantable cardiac rhythm management devices--Dimensional and test requirements. 3-111............................ .............. ANSI/AAMI/ISO 25539-3:2011 Transferred. See 3-103. Cardiovascular implants-- Endovascular devices--Part 3: Vena cava filters. 3-112............................ .............. ANSI/AAMI/ISO 7199:2009 Transferred. See 3-124. Cardiovascular implants and artificial organs--Blood gas exchangers (oxygenators). 3-117............................ .............. ANSI/AAMI/ISO 81060-2 Second Transferred. See 3-122. edition 2013-05-01 Non-invasive sphygmomanometers--Part 2: Clinical validation of automated measurement type. 3-120............................ .............. ANSI/AAMI/ISO 25539-2:2012 Transferred. See 3-116. Cardiovascular implants-- Endovascular devices--Part 2: Vascular stents. 3-124............................ 3-150 ISO 7199 Third edition 2016-11- Withdrawn and replaced with 15 Cardiovascular implants and newer version. artificial organs--Blood-gas exchangers (oxygenators). 3-128............................ .............. ANSI/AAMI/ISO 14117:2012 Active Transferred. See 3-139. implantable medical devices-- Electromagnetic compatibility-- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices. 3-130............................ 3-151 ANSI/AAMI/IEC 80601-2-30:2009 & Reaffirmation. Extent of A1:2013/(R2016) Medical Recognition. Transferred. electrical equipment--Part 2- See 3-123. 30: Particular requirements for the basic safety and essential performance of automated non- invasive sphygmomanometers. 3-131............................ .............. ANSI/AAMI/ISO 27185:2012 Cardiac Transferred. See 3-132. rhythm management devices-- Symbols to be used with cardiac rhythm management device labels, and information to be supplied--General requirements. 3-140............................ .............. ANSI/AAMI/ISO 5840-3:2013 Transferred. See 3-133. Cardiovascular implants-- Cardiac valve prostheses--Part 3: Heart valve substitutes implanted by transcatheter techniques. 3-141............................ .............. ANSI/AAMI/ISO 5841-3:2013 Transferred. See 3-125. Implants for surgery--Cardiac pacemakers--Part 3: Low-profile connectors (IS-1) for implantable pacemakers. 3-146............................ .............. ANSI/AAMI/ISO 5840-1:2015 Transferred. See 3-145. Cardiovascular implants-- Cardiac valve prostheses--Part 1: General requirements. 3-148............................ .............. ANSI/AAMI/ISO 5840-2:2015 Transferred. See 3-147. Cardiovascular implants-- Cardiac valve prostheses--Part 2: Surgically implanted heart valve substitutes. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-50............................. .............. ADA Specification No. 18: 1992 Withdrawn. See 4-240. Alginate Impression Materials. 4-89............................. .............. ANSI/ADA Specification No. 53 Reaffirmation. Reaffirmed by ANSI: August 2013 Polymer-Based Crown and Bridge Materials. 4-91............................. .............. ANSI/ADA Standard No. 80/ISO Transferred. See 4-241. 7491:2000 Reaffirmed by ANSI: May 2013 Dental Materials-- Determination of Color Stability. 4-119............................ .............. ANSI/ADA Specification No. Withdrawn. See 4-240. 82:1998/ISO 13716:1999 Reaffirmed by ANSI: January 2009 Dental Reversible/ Irreversible Hydrocolloid Impression Material Systems. 4-193............................ .............. ANSI/ADA Standard No. 15-2008/ Transferred. See 4-151. ISO 22112:2005 Reaffirmed by ANSI: May 2013 Artificial Teeth for Dental Prostheses. 4-230............................ .............. ANSI/ADA Standard No. 30/ISO Transferred. See 4-198. 3107:2011 Approved by ANSI: February 2013 Dental Zinc Oxide/ Eugenol & Zinc Oxide/Non- Eugenol Cements. 4-235............................ .............. ANSI/ADA Standard No. 100/ISO Transferred. See 4-218. 27020:2010 Approved by ANSI: November 2012 Orthodontic Brackets and Tubes. 4-237............................ .............. ANSI/ADA Standard No.120-2009/ Transferred. See 4-238. ISO 20127:2005 Reaffirmed by ANSI: September 8, 2014 Powered Toothbrushes. ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management) (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-65............................. .............. ANSI/AAMI/ISO 80369-1:2010 Small Transferred. See 5-63. bore connectors for liquids and gases in healthcare applications--Part 1: General requirements. 5-70............................. .............. ANSI/AAMI/ISO 14971:2007/(R)2010 Transferred. See 5-40. (Corrected 4 October 2007) Medical devices--Application of risk management to medical devices. 5-92............................. .............. ANSI/AAMI/IEC 60601-1-8:2006 and Transferred. See 5-76. A1:2012 Medical Electrical Equipment--Part 1-8: General requirements for basic safety and essential performance-- Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. 5-96............................. .............. ANSI/AAMI/IEC 62366-1:2015 Transferred. See 5-114. Medical devices--Part 1: Application of usability engineering to medical devices. [[Page 26469]] 5-100............................ .............. ANSI/AAMI/ISO 80369-20:2015 Transferred. See 5-97. Small-bore connectors for liquids and gases in healthcare applications--Part 20: Common test methods. 5-118............................ .............. ANSI/AAMI/ISO 15223-1:2016 Transferred. See 5-117. Medical devices--Symbols to be used with medical device labels, labelling and information to be supplied-- Part 1: General requirements. 5-119............................ .............. ANSI/AAMI/ISO 80369-5:2016 Small- Transferred. See 5-107. bore connectors for liquids and gases in healthcare applications--Part 5: Connectors for limb cuff inflation applications. ---------------------------------------------------------------------------------------------------------------- F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ---------------------------------------------------------------------------------------------------------------- 19-2............................. .............. ANSI/AAMI/IEC 60601-1-2:2007 Transferred. See 19-1. (R2012) Medical electrical equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic compatibility-- Requirements and tests. 19-12............................ .............. ANSI/AAMI/IEC 60601-1-2:2014 Transferred. See 19-8. Medical electrical equipment-- Part 1-2: General requirements for basic safety and essential performance--Collateral Standard: Electromagnetic disturbances--Requirements and tests. ---------------------------------------------------------------------------------------------------------------- G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-149............................ 6-401 ASTM D7160-16 Standard Practice Withdrawn and replaced with for Determination of Expiration newer version. Dating for Medical Gloves. 6-178............................ .............. ASTM D6124-06 (Reapproved 2017) Reaffirmation. Standard Test Method for Residual Powder on Medical Gloves. 6-214............................ .............. ASTM D6355-07 (Reapproved 2017) Reaffirmation. Standard Test Method for Human Repeat Insult Patch Testing of Medical Glove. 6-217............................ 6-402 ASTM F1670/F1670M-17 Standard Withdrawn and replaced with Test Method for Resistance of newer version. Materials Used in Protective Clothing to Penetration by Synthetic Blood. 6-227............................ .............. ANSI/AAMI/IEC 60601-2-21:2009 Transferred. See 6-388. Medical electrical equipment-- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers. 6-229............................ .............. ANSI/AAMI/IEC 60601-2-2:2009 Transferred. See 6-389. Medical electrical equipment-- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment. 6-232............................ 6-403 ISO 80601-2-56 Second edition Withdrawn and replaced with 2017-03 Medical electrical newer version. equipment--Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. 6-230............................ .............. ANSI/AAMI/IEC 60601-2-19:2009 Transferred. See 6-385. Medical electrical equipment-- Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators. 6-235............................ .............. ANSI/AAMI/IEC 60601-2-50:2009 Transferred. See 6-387. Medical electrical equipment-- Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment. 6-270............................ .............. ASTM F1840-10 (Reapproved 2016) Reaffirmation. Standard Terminology for Surgical Suture Needles. 6-304............................ 6-404 ISO 7886-1 Second edition 2017- Withdrawn and replaced with 05 Sterile hypodermic syringes newer version. for single use--Part 1: Syringes for manual use. 6-307............................ 6-405 IEC 80601-2-59 Edition 2.0 2017- Withdrawn and replaced with 09 Medical electrical newer version. equipment--Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening. 6-323............................ 6-406 ASTM F1862/F1862M-17 Standard Withdrawn and replaced with Test Method for Resistance of newer version. Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity). 6-337............................ .............. ANSI/AAMI/IEC 60601-2-20:2009 Transferred. See 6-386. Medical electrical equipment-- Part 2-20: Particular requirements for the basic safety and essential performance of transport incubators [Including AMENDMENT 1 (2016)]. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-271............................ .............. CLSI M100 27th Edition Extent of recognition. Performance Standards for Antimicrobial Susceptibility Testing. ---------------------------------------------------------------------------------------------------------------- [[Page 26470]] I. Materials ---------------------------------------------------------------------------------------------------------------- 8-113............................ .............. ASTM F1147-05 (Reapproved 2017) Reaffirmation. [egr]\1\ Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings. 8-337............................ .............. ASTM F621-12 (Reapproved 2017) Reaffirmation. Standard Specification for Stainless Steel Forgings for Surgical Implants. 8-356............................ .............. ASTM F67-13 (Reapproved 2017) Reaffirmation. Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). 8-446............................ 8-460 ASTM F2848-17 Standard Withdrawn and replaced with Specification for Medical-Grade newer version. Extent of Ultra-High Molecular Weight recognition. Polyethylene Yarns. ---------------------------------------------------------------------------------------------------------------- J. Nanotechnology ---------------------------------------------------------------------------------------------------------------- No new entries at this time ........................... ---------------------------------------------------------------------------------------------------------------- K. Neurology ---------------------------------------------------------------------------------------------------------------- 17-1............................. .............. ANSI/AAMI NS28:1988/(R)2015 Reaffirmation. Extent of Intracranial pressure recognition. monitoring devices. 17-8............................. 17-15 ISO 14708-3 Second edition 2017- Withdrawn and replaced with 04 Implants for surgery--Active newer version. implantable medical devices-- Part 3: Implantable neurostimulators. 17-10............................ .............. ANSI/AAMI/ISO 14708-3:2008/ Withdrawn. (R)2011 Implants for surgery-- Active implantable medical devices--Part 3: Implantable neurostimulators. 17-11............................ 17-16 IEC 60601-2-10 Edition 2.1 2016- Withdrawn and replaced with 04 Medical electrical newer version. equipment--Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. ---------------------------------------------------------------------------------------------------------------- L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ---------------------------------------------------------------------------------------------------------------- 9-64............................. .............. ANSI/AAMI/IEC 60601-2-2:2009 Withdrawn. Duplicate Medical electrical equipment-- recognition. See 6-229. Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. 9-66............................. .............. ANSI/AAMI/ISO 8638:2010 Transferred. See 9-89. Cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters. 9-81............................. .............. ANSI/AAMI/IEC 60601-2-16:2012 Transferred. See 9-80 Medical electrical equipment-- Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. 9-91............................. .............. ANSI/AAMI/ISO 8637:2010 Transferred. See 9-92. Cardiovascular implants and extracorporeal systems-- Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [Including AMENDMENT 1 (2013)]. 9-91............................. 9-114 IEC 60601-2-18: Edition 3.0 2009- Withdrawn and replaced with 08, medical electrical new recognition number. equipment--part 2-18: particular requirements for the basic safety and essential performance of endoscopic equipment. 9-93............................. 9-115 ISO 25841 Third edition 2017-08 Withdrawn and replaced with Female condoms--Requirements newer version. and test methods. 9-103............................ .............. ANSI/AAMI/ISO 26722:2014 Water Transferred. See 9-101. treatment equipment for haemodialysis applications and related therapies. 9-104............................ .............. ANSI/AAMI/ISO 13958:2014 Transferred. See 9-97. Concentrates for hemodialysis and related therapies. 9-105............................ .............. ANSI/AAMI/ISO 13959:2014 Water Transferred. See 9-98. for hemodialysis and related therapies. 9-106............................ .............. ANSI/AAMI/ISO 11663:2014 Quality Transferred. See 9-100. of dialysis fluid for hemodialysis and related therapies. 9-107............................ .............. ANSI/AAMI/ISO 23500:2014 Transferred. See 9-99. Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. ---------------------------------------------------------------------------------------------------------------- M. Ophthalmic ---------------------------------------------------------------------------------------------------------------- 10-43............................ 10-105 ISO 11979-8 Third edition 2017- Withdrawn and replaced with 04 Ophthalmic Implants-- newer version. Intraocular lenses--Part 8: Fundamental requirements. 10-46............................ 10-106 ISO 18369-3 Second edition 2017- Withdrawn and replaced with 08 Ophthalmic optics--Contact newer version. lenses--Part 3: Measurement methods. 10-54............................ 10-107 ISO 18369-4 Second edition 2017- Withdrawn and replaced with 08 Ophthalmic optics--Contact newer version. lenses--Part 4: Physicochemical properties of contact lens materials. 10-80............................ 10-108 ISO 18369-2 Third edition 2017- Withdrawn and replaced with 08 Ophthalmic optics--Contact newer version. lenses--Part 2: Tolerances. [[Page 26471]] 10-83............................ 10-109 ISO 18369-1 Second edition 2017- Withdrawn and replaced with 08 Ophthalmic optics--Contact newer version. lenses--Part 1: Vocabulary, classification system and recommendations for labelling specifications. ---------------------------------------------------------------------------------------------------------------- N. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-259........................... .............. ASTM F2887--12 Standard Withdrawn. See 11-321. Specification for Total Elbow Prostheses. ---------------------------------------------------------------------------------------------------------------- O. Physical Medicine ---------------------------------------------------------------------------------------------------------------- 16-200........................... 16-201 ISO 7176-19 Second edition 2008- Withdrawn and replaced with 07-15 AMENDMENT 1 2015-11-15. a newer version including Wheelchairs--Part 19: Wheeled amendment. mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]. ---------------------------------------------------------------------------------------------------------------- P. Radiology ---------------------------------------------------------------------------------------------------------------- 12-139........................... .............. NEMA UD 2-2004 (R2009) Acoustic Withdrawn. Duplicate Output Measurement Standard for recognition. See 12-105. Diagnostic Ultrasound Equipment, Revision 3. 12-202........................... 12-308 IEC 60601-2-43 Edition 2.1 2017- Withdrawn and replaced with 05 CONSOLIDATED VERSION Medical newer version. electrical equipment--Part 2- 43: Particular requirements for the safety and essential performance of X-Ray Equipment for interventional procedures. 12-204........................... 12-309 IEC 60601-2-28 Edition 3.0 2017- Withdrawn and replaced with 06 Medical electrical newer version. equipment--Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. 12-251........................... 12-310 IEC 60601-2-63 Edition 1.1 2017- Withdrawn and replaced with 07 CONSOLIDATED VERSION Medical newer version. electrical equipment--Part 2- 63: Particular requirements for the basic safety and essential performance of dental extra- oral X-Ray equipment. 12-252........................... 12-311 IEC 60601-2-65 Edition 1.1 2017- Withdrawn and replaced with 05 CONSOLIDATED VERSION Medical newer version. electrical equipment--Part 2- 65: Particular requirements for the basic safety and essential performance of dental intra- oral X-Ray equipment. 12-227........................... 12-312 IEC 61391-1 Edition 1.1 2017-07 Withdrawn and replaced with CONSOLIDATED VERSION newer version. Ultrasonics--Pulse-echo scanners--Part 1: Techniques for calibrating spatial measurement systems and measurement of system point- spread function response. 12-276........................... 12-313 IEC TS 62462 Edition 2.0 2017-07 Withdrawn and replaced with Ultrasonics--Output test-- newer version. Guidance for the maintenance of ultrasound physiotherapy systems. 12-155........................... 12-314 ISO 11554 Fourth edition 2017-07 Withdrawn and replaced with Optics and photonics--Lasers newer version. and laser-related equipment-- Test methods for laser beam power, energy and temporal characteristics. 12-192........................... 12-315 NEMA Standards Publication MS 8- Withdrawn and replaced with 2016 Characterization of the newer version. Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems. 12-258........................... 12-316 IEC 62359 Edition 2.1 2017-09 Withdrawn and replaced with CONSOLIDATED VERSION newer version. Ultrasonics--Field characterization--Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. ---------------------------------------------------------------------------------------------------------------- Q. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-39............................ .............. ANSI/AAMI/IEC 80001-1:2010 Transferred. See 13-38. Application of risk management for IT Networks incorporating medical devices--Part 1: Roles, responsibilities and activities. 13-41............................ .............. ANSI/AAMI/IEC TIR80001-2-1:2012 Transferred. See 13-40. Application of risk management for IT-networks incorporating medical devices--Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples. 13-43............................ .............. ANSI/AAMI/IEC TIR80001-2-2:2012 Transferred. See 13-42. Technical Information Report Application of risk management for IT-networks incorporating medical devices--Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls. 13-45............................ .............. ANSI/AAMI/IEC TIR80001-2-3:2012 Transferred. See 13-44. Technical Information Report Application of risk management for IT-networks incorporating medical devices--Part 2-3: Guidance for wireless networks. [[Page 26472]] 13-64............................ .............. ANSI/AAMI/IEC TIR80001-2-4:2012 Transferred. See 13-63. Technical Information Report Application of risk management for IT-networks incorporating medical devices--Part 2-4: General implementation guidance for healthcare delivery organizations. ---------------------------------------------------------------------------------------------------------------- R. Sterility ---------------------------------------------------------------------------------------------------------------- 14-221........................... .............. ANSI/AAMI/ISO TIR 11139:2006 Transferred. See 14-325. Sterilization of health care products--Vocabulary. 14-222........................... .............. ANSI/AAMI/ISO 18472:2006/(R)2010 Transferred. See 14-354. Sterilization of health care products--Biological and chemical indicators--Test equipment. 14-227........................... .............. ANSI/AAMI/ISO 11737-1:2006 Transferred. See 14-407. (R)2011 Sterilization of health care products--Microbiological methods--Part 1: Determination of the population of microorganisms on product. 14-238........................... .............. ANSI/AAMI/ISO 11140-5:2007/ Transferred. See 14-332. (R)2012 Sterilization of health care products--Chemical indicators--Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs. 14-261........................... .............. ANSI/AAMI/ISO 17665-1:2006/ Transferred. See 14-333. (R)2013 Sterilization of health care products--Moist heat--Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. 14-274........................... .............. ANSI/AAMI/ISO 15882:2008/(R)2013 Transferred. See 14-334. Sterilization of health care products--Chemical indicators-- Guidance for selection, use and interpretation of results. 14-278........................... .............. ANSI/AAMI/ISO 10993- Transferred. See 14-408. 7:2008(R)2012 Biological evaluation of medical devices-- Part 7: Ethylene oxide sterilization residuals. 14-285........................... .............. ANSI/AAMI/ISO 14161:2009/(R)2014 Transferred. See 14-336. Sterilization of health care products--Biological indicators--Guidance for the selection, use and interpretation of results. 14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Transferred. See 14-327. (R)2014 Sterilization of medical devices-- Microbiological methods--Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. 14-291........................... .............. ANSI/AAMI/ISO 14937:2009/(R)2013 Transferred. See 14-337. Sterilization of health care products--General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices. 14-295........................... .............. ANSI/AAMI ST81:2004/(R)2016 Reaffirmation. Sterilization of medical devices--Information to be provided by the manufacturer for the processing of resterilizable medical devices. 14-298........................... .............. ANSI/AAMI/ISO 11137-3:2006/ Withdrawn. See 14-510. (R)2010 Sterilization of health care products--Radiation--Part 3: Guidance on dosimetric aspects. 14-330........................... 14-510 ISO 11137-3 Second edition 2017- Withdrawn and replaced with 06 Sterilization of health care newer version. products--Radiation--Part 3: Guidance on dosimetric aspects of development, validation and routine control. 14-339........................... .............. ANSI/AAMI/ISO 20857:2010/(R)2015 Transferred. See 14-340. Sterilization of health care products--Dry heat-- Requirements for the development, validation and routine control of a sterilization process for medical devices. 14-348........................... .............. ANSI/AAMI/ISO 13408-2:2003/ Transferred. See 14-138. (R)2013 Aseptic processing of health care products--Part 2: Filtration. 14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Transferred. See 14-239. (R)2015 Aseptic processing of health care products--Part 3: Lyophilization. 14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Transferred. See 14-191. (R)2014 Aseptic processing of health care products--Part 4: Clean-in-place technologies. 14-351........................... .............. ANSI/AAMI/ISO 13408-5:2006/ Transferred. See 14-240. (R)2015 Aseptic processing of health care products--Part 5: Sterilization in place. 14-358........................... .............. ANSI/AAMI/ISO 14160:2011/(R)2016 Transferred. See 14-361. Sterilization of health care products--Liquid chemical sterilizing agents for single- use medical devices utilizing animal tissues and their derivatives--Requirements for characterization, development, validation and routine control of a sterilization process for medical devices. 14-376........................... .............. ANSI/AAMI/ISO TIR 17665-2:2009 Transferred. See 14-277. Sterilization of health care products--Moist heat--Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1. 14-387........................... .............. ANSI/AAMI/ISO 13408-7:2012 Transferred. See 14-388. Aseptic processing of health care products--Part 7: Alternative processes for medical devices and combination products. 14-425........................... .............. ANSI/AAMI/ISO 13408-6:2005/(R) Transferred. See 14-424. 2013 & A1:2013 Aseptic processing of health care products--Part 6: Isolator systems [Including AMENDMENT1 (2013)]. [[Page 26473]] 14-426........................... .............. ANSI/AAMI/ISO 13408-1:2008 Transferred. See 14-427. (R2011) Aseptic processing of health care products--Part 1: General requirements [Including AMENDMENT1 (2013)]. 14-438........................... .............. ANSI/AAMI/ISO 11137-2:2013 Transferred. See 14-409. Sterilization of health care products--Radiation--Part 2: Establishing the sterilization dose. 14-439........................... 14-511 ANSI/AAMI ST79:2017 Withdrawn and replaced with Comprehensive guide to steam newer version. sterilization and sterility assurance in health care facilities. 14-457........................... .............. ANSI/AAMI/ISO 11607-1:2006/ Transferred. See 14-454. (R)2010 Packaging for terminally sterilized medical devices--Part 1: Requirements for materials, sterile barrier systems and packaging [Including AMENDMENT 1 (2013)]. 14-458........................... .............. ANSI/AAMI/ISO 11607-2:2006/ Transferred. See 14-455. (R)2010 Packaging for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes [Including AMENDMENT 1 (2013)]. 14-459........................... .............. ANSI/AAMI/ISO 11140-1:2014 Transferred. See 14-460. Sterilization of health care products--Chemical indicators-- Part 1: General requirements. 14-461........................... .............. ANSI/AAMI/ISO 11137-1:2006/ Transferred. See 14-428. (R)2010 Sterilization of health care products--Radiation--Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013)]. 14-479........................... .............. ANSI/AAMI/ISO 11135:2014 Transferred. See 14-452. Sterilization of health care products--Ethylene oxide-- Requirements for development, validation and routine control of a sterilization process for medical devices. ---------------------------------------------------------------------------------------------------------------- S. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-17............................ .............. ASTM F2311-08 Standard Guide for Withdrawn. Classification of Therapeutic Skin Substitutes. 15-23............................ .............. ASTM F2739-08 Standard Guide for Withdrawn. See 15-50. Quantitating Cell Viability within Biomaterial Scaffolds. 15-37............................ 15-51 ASTM F2347-15 Standard Guide for Withdrawn and replaced with Characterization and Testing of newer version. Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications. 15-42............................ 15-52 ASTM F2064-17 Standard Guide for Withdrawn and replaced with Characterization and Testing of newer version. Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications. ---------------------------------------------------------------------------------------------------------------- \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 049. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and Date ------------------------------------------------------------------------ A. Anesthesiology ------------------------------------------------------------------------ 1-131................ Medical suction equipment--Part ISO 10079-1 1: Electrically powered Third Edition suction equipment. 2015-11-01. 1-132................ Medical suction equipment--Part ISO 10079-2 2: Manually powered suction Third Edition equipment. 2014-05-01. 1-133................ Medical suction equipment--Part ISO 10079-3 3: Suction equipment powered Third Edition from a vacuum or positive 2014-05-01. pressure gas source. 1-134................ Biocompatibility evaluation of ISO 18562-1 breathing gas pathways in First edition healthcare applications--Part 2017-03. 1: Evaluation and testing within a risk management process. 1-135................ Biocompatibility evaluation of ISO 18562-2 breathing gas pathways in First edition healthcare applications--Part 2017-03. 2: Tests for emissions of particulate matter. 1-136................ Biocompatibility evaluation of ISO 18562-3 breathing gas pathways in First edition healthcare applications--Part 2017-03. 3: Tests for emissions of volatile organic compounds. 1-137................ Biocompatibility evaluation of ISO 18562-4 breathing gas pathways in First edition healthcare applications--Part 2017-03. 4: Tests for leachables in condensate. 1-138................ Medical electrical equipment-- ISO 80601-2-74 Part 2-74: Particular First edition requirements for basic safety 2017-05. and essential performance of respiratory humidifying equipment. ------------------------------------------------------------------------ [[Page 26474]] B. Biocompatibility ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ C. Cardiovascular ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ D. Dental/Ear, Nose, and Throat (ENT) ------------------------------------------------------------------------ 4-240................ Dentistry--Hydrocolloid ISO 21563 First impression materials. edition 2013-08- 15. 4-241................ Dental materials--Determination ISO 7491 Second of colour stability. edition 2000-09- 01. ------------------------------------------------------------------------ E. General I (Quality Systems/Risk Management) (QS/RM) ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ G. General Hospital/General Plastic Surgery (GH/GPS) ------------------------------------------------------------------------ 6-407................ Standard Specification for ASTM F3186-17. Adult Portable Bed Rails and Related Products. ------------------------------------------------------------------------ H. In Vitro Diagnostics (IVD) ------------------------------------------------------------------------ 7-274................ Verification and Validation of CLSI MM17-A Vol. Multiplex Nucleic Acid Assays; 28 No. 9 Approved Guideline. (Replaces MM17- P Vol. 27 No. 21). ------------------------------------------------------------------------ I. Materials ------------------------------------------------------------------------ 8-461................ Standard Guide for Selecting ASTM F3208-17. Test Soils for Validation of Cleaning Methods for Reusable Medical Devices. 8-462................ Standard Test Method for ASTM F3260-17. Determining the Flexural Stiffness of Medical Textiles. 8-463................ Standard Guide for Additive ISO/ASTM 52901 Manufacturing--General First edition Principles--Requirements for 2017-08. Purchased AM Parts. 8-464................ Assessment of the safety of ISO 10974 Second magnetic resonance imaging for edition 2018. patients with an active implantable medical device. ------------------------------------------------------------------------ J. Nanotechnology ------------------------------------------------------------------------ 18-9................. Nanotechnologies--Guidance on ISO/TR 13014 physico-chemical First edition characterization of engineered 2012-05-15. nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. 18-10................ Nanotechnologies--Endotoxin ISO 29701 First test on nanomaterial samples edition 2010-09- for in vitro systems--Limulus 15. amebocyte lysate (LAL) test. ------------------------------------------------------------------------ K. Neurology ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ------------------------------------------------------------------------ 9-115................ Condoms--Guidance on clinical ISO 29943-1 studies--Part 1: Male condoms, First edition clinical function studies 2017-07. based on self-reports. 9-116................ Condoms--Guidance on clinical ISO 29943-2 studies--Part 2: Female First edition condoms, clinical function 2017-07. studies based on self-reports. ------------------------------------------------------------------------ M. Ophthalmic ------------------------------------------------------------------------ 10-110............... Ophthalmic implants--Ophthalmic ISO 15798 Third viscosurgical devices edition 2013-09- [Including AMENDMENT 1 (2017)]. 15 AMENDMENT 1 2017-05. ------------------------------------------------------------------------ N. Orthopedic ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ [[Page 26475]] O. Physical Medicine ------------------------------------------------------------------------ 16-202............... RESNA Standard for Wheelchairs RESNA WC-4:2017. Volume 4: Wheelchairs and Transportation. ------------------------------------------------------------------------ P. Radiology ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ Q. Software/Informatics ------------------------------------------------------------------------ 13-104............... Software Cybersecurity for ANSI/UL 2900-2- Network-Connectable Products, 1, First Part 2-1: Particular Edition Requirements for Network September 1, Connectable Components of 2017. Healthcare and Wellness Systems. ------------------------------------------------------------------------ R. Sterility ------------------------------------------------------------------------ No new entries at this time ................ ------------------------------------------------------------------------ S. Tissue Engineering ------------------------------------------------------------------------ 15-53................ Standard Guide for Assessing ASTM F3206 -17. Medical Device Cytocompatibility with Delivered Cellular Therapies. 15-54................ Standard Guide for in vivo ASTM F3207-17. Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will be incorporating the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will be announcing additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with recognition list 049, FDA will no longer include in the database the CDRH Office and Division associated with recognized standards, Devices Affected, and Processes Affected. Beginning with recognition list 049 FDA will automatically incorporate, upon publication, a U.S. parallel adoption of an existing recognized international standard. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to [email protected]. To be considered, such recommendations should contain, at a minimum, the following information available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm. Dated: May 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12222 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26465
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)
Health care providers (Primary Care TBI Provider Survey ......................... 600 1 15/60 150
Physician, Emergency Physician,
Nurse Practitioner and Physician
Assistant).
Focus group screener ...................... 36 1 5/60 3
Focus group questionnaire .............. 31 1 5/60 3
Focus group discussion guide ......... 31 1 85/60 44
Total ........................................... ........................................................... ........................ ........................ ........................ 200
Jeffrey M. Zirger, instructions for submitting comments. https://www.regulations.gov or at the
Acting Chief, Information Collection Review Comments submitted electronically, Dockets Management Staff between 9
Office, Office of Scientific Integrity, Office including attachments, to https:// a.m. and 4 p.m., Monday through
of the Associate Director for Science, Office www.regulations.gov will be posted to Friday. FDA will consider any
of the Director, Centers for Disease Control the docket unchanged. Because your comments received in determining
and Prevention. comment will be made public, you are whether to amend the current listing of
[FR Doc. 2018–12251 Filed 6–6–18; 8:45 am] solely responsible for ensuring that your modifications to the list of recognized
BILLING CODE 4163–18–P comment does not include any standards, Recognition List Number:
confidential information that you or a 049.
third party may not wish to be posted, • Confidential Submissions—To
DEPARTMENT OF HEALTH AND such as medical information, your or submit a comment with confidential
HUMAN SERVICES anyone else’s Social Security number, or information that you do not wish to be
confidential business information, such made publicly available, submit your
Food and Drug Administration comments only as a written/paper
as a manufacturing process. Please note
[Docket No. FDA–2004–N–0451] that if you include your name, contact submission. You should submit two
information, or other information that copies total. One copy will include the
Food and Drug Administration identifies you in the body of your information you claim to be confidential
Modernization Act of 1997: comments, that information will be with a heading or cover note that states
Modifications to the List of Recognized posted on https://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS
Standards, Recognition List Number: • If you want to submit a comment CONFIDENTIAL INFORMATION’’. The
049 with confidential information that you Agency will review this copy, including
do not wish to be made available to the the claimed confidential information, in
AGENCY: Food and Drug Administration, its consideration of comments. The
public, submit the comment as a
HHS. second copy, which will have the
written/paper submission and in the
ACTION: Notice. manner detailed (see ‘‘Written/Paper claimed confidential information
Submissions’’ and ‘‘Instructions’’). redacted/blacked out, will be available
SUMMARY: The Food and Drug for public viewing and posted on
Administration (FDA or Agency) is Written/Paper Submissions https://www.regulations.gov. Submit
announcing a publication containing Submit written/paper submissions as both copies to the Dockets Management
modifications the Agency is making to follows: Staff. If you do not wish your name and
the list of standards FDA recognizes for • Mail/Hand delivery/Courier (for contact information to be made publicly
use in premarket reviews (FDA written/paper submissions): Dockets available, you can provide this
Recognized Consensus Standards). This Management Staff (HFA–305), Food and information on the cover sheet and not
publication, entitled ‘‘Modifications to Drug Administration, 5630 Fishers in the body of your comments and you
the List of Recognized Standards, Lane, Rm. 1061, Rockville, MD 20852. must identify this information as
Recognition List Number: 049’’ • For written/paper comments ‘‘confidential.’’ Any information marked
(Recognition List Number: 049), will submitted to the Dockets Management as ‘‘confidential’’ will not be disclosed
assist manufacturers who elect to Staff, FDA will post your comment, as except in accordance with 21 CFR 10.20
declare conformity with consensus well as any attachments, except for and other applicable disclosure law. For
standards to meet certain requirements information submitted, marked and more information about FDA’s posting
for medical devices. identified, as confidential, if submitted of comments to public dockets, see 80
DATES: These modifications to the list of as detailed in ‘‘Instructions.’’ FR 56469, September 18, 2015, or access
recognized standards are applicable Instructions: All submissions received the information at: https://www.gpo.gov/
June 7, 2018. must include the Docket No. FDA– fdsys/pkg/FR-2015-09-18/pdf/2015-
2004–N–0451 for ‘‘Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES: You may submit comments 23389.pdf.
as follows: Administration Modernization Act of Docket: For access to the docket to
1997: Modifications to the List of read background documents or the
Electronic Submissions Recognized Standards, Recognition List electronic and written/paper comments
Submit electronic comments in the Number: 049.’’ Received comments will received, go to https://
following way: be placed in the docket and, except for www.regulations.gov and insert the
• Federal eRulemaking Portal: those submitted as ‘‘Confidential docket number, found in brackets in the
https://www.regulations.gov. Follow the Submissions,’’ publicly viewable at heading of this document, into the
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/1.svg)
![26466 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
‘‘Search’’ box and follow the prompts I. Background list of FDA Recognized Consensus
and/or go to the Dockets Management Section 204 of the Food and Drug Standards. Additional information on
Staff, 5630 Fishers Lane, Rm. 1061, Administration Modernization Act of the Agency’s standards program is
Rockville, MD 20852. 1997 (FDAMA) (Pub. L. 105–115) available at https://www.fda.gov/
An electronic copy of Recognition List amended section 514 of the Federal MedicalDevices/DeviceRegulationand
Food, Drug, and Cosmetic Act (FD&C Guidance/Standards/default.htm.
Number: 049 is available on the internet
at https://www.fda.gov/MedicalDevices/ Act) (21 U.S.C. 360d). Amended section II. Modifications to the List of
DeviceRegulationandGuidance/ 514 allows FDA to recognize consensus Recognized Standards, Recognition List
Standards/ucm123792.htm. standards developed by international Number: 049
and national organizations for use in
See section IV for electronic access to satisfying portions of device premarket FDA is announcing the addition,
the searchable database for the current review submissions or other withdrawal, correction, and revision of
list of FDA recognized consensus requirements. certain consensus standards the Agency
standards, including Recognition List In the Federal Register notice of is recognizing for use in premarket
Number: 049 modifications and other February 25, 1998 (63 FR 9561), FDA submissions and other requirements for
standards related information. Submit announced the availability of a guidance devices. FDA is incorporating these
written requests for a single hard copy entitled ‘‘Recognition and Use of modifications to the list of FDA
of the document entitled ‘‘Modifications Consensus Standards.’’ The notice Recognized Consensus Standards in the
to the List of Recognized Standards, described how FDA would implement Agency’s searchable database. FDA is
Recognition List Number: 049’’ to Scott its standard recognition program and using the term ‘‘Recognition List
Colburn, Center for Devices and provided the initial list of recognized Number: 049’’ to identify the current
Radiological Health, Food and Drug standards. The guidance was updated in modifications.
Administration, 10903 New Hampshire September 2007 and is available at
In table 1, FDA describes the
Ave., Bldg. 66, Rm. 5514, Silver Spring, https://www.fda.gov/MedicalDevices/
following modifications: (1) The
DeviceRegulationandGuidance/
MD 20993. Send one self-addressed withdrawal of standards and their
GuidanceDocuments/ucm077274.htm.
adhesive label to assist that office in Modifications to the initial list of replacement by others, if applicable; (2)
processing your request, or fax your recognized standards, as published in the correction of errors made by FDA in
request to 301–847–8144. the Federal Register, can be accessed at listing previously recognized standards;
https://www.fda.gov/MedicalDevices/ and (3) the changes to the
FOR FURTHER INFORMATION CONTACT:
DeviceRegulationandGuidance/ supplementary information sheets of
Scott Colburn, Center for Devices and recognized standards that describe
Radiological Health, Food and Drug Standards/ucm123792.htm.
These notices describe the addition, revisions to the applicability of the
Administration, 10903 New Hampshire standards.
Ave., Bldg. 66, Rm. 5514, Silver Spring, withdrawal, and revision of certain
standards recognized by FDA. The In section III, FDA lists modifications
MD 20993, 301–796–6287,
Agency maintains hypertext markup the Agency is making that involve the
CDRHStandardsStaff@fda.hhs.gov.
language (HTML) and portable initial addition of standards not
SUPPLEMENTARY INFORMATION: document format (PDF) versions of the previously recognized by FDA.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
A. Anesthesiology
1–86 .................. ........................ ISO 8185 Third edition 2008–06–15 (Corrected version), Respiratory Withdrawn. See 1–138.
tract humidifiers for medical use—Particular requirements for res-
piratory humidification systems.
1–95 .................. ........................ ISO 5366–3 Second edition 2001–08–15 Anaesthetic and Respiratory Withdrawn. See 1–117.
Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy
Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)].
1–107 ................ ........................ ANSI/AAMI/ISO 5356–1:2004 Anaesthetic and respiratory equip- Transferred. See 1–62.
ment—Conical connectors—Part 1: Cones and sockets.
1–109 ................ ........................ ANSI/AAMI/ISO 5362:2006 Anaesthetic reservoir bags ......................... Transferred. See 1–75.
1–121 ................ 1–129 ISO 5359 Fourth edition 2014–10–01 Anaesthetic and respiratory Withdrawn and replaced with
equipment—Low-pressure hose assemblies for use with medical newer version including amend-
gases [Including AMENDMENT 1 (2017)]. ment.
1–128 ................ 1–130 ISO 18082 First edition 2014–06–15 Anaesthetic and respiratory Withdrawn and replaced with
equipment—Dimensions of noninterchangeable screw-threaded newer version including amend-
(NIST) low-pressure connectors for medical gases [Including ment.
AMENDMENT 1 (2017)].
sradovich on DSK3GMQ082PROD with NOTICES
B. Biocompatibility
2–118 ................ ........................ ANSI/AAMI/ISO 10993–11:2006/(R)2010 Biological evaluation of med- Transferred. See 2–176.
ical devices—Part 11: Tests for systemic toxicity.
2–120 ................ ........................ ANSI/AAMI/ISO 10993–6:2007/(R)2014 Biological evaluation of med- Withdrawn.
ical devices—Part 6: Tests for local effects after implantation.
2–153 ................ ........................ ANSI/AAMI/ISO 10993–5:2009/(R)2014 Biological evaluation of med- Transferred. See 2–245.
ical devices—Part 5: Tests for in vitro cytotoxicity.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/2.svg)
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26467
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
2–156 ................ ........................ ANSI/AAMI/ISO 10993–1:2009/(R)2013 Biological evaluation of med- Transferred. See 2–220.
ical devices—Part 1: Evaluation and testing within a risk manage-
ment process.
2–163 ................ ........................ ANSI/AAMI/ISO 10993–9:2009/(R)2014 Biological evaluation of med- Transferred. See 2–168.
ical devices—Part 9: Framework for identification and quantification
of potential degradation products.
2–165 ................ ........................ ANSI/AAMI/ISO 10993–14:2001/(R) 2011 Biological evaluation of Transferred. See 2–170.
medical devices—Part 14: Identification and quantification of deg-
radation products form ceramics.
2–171 ................ 2–249 ISO 10993–16 Third edition 2017–05 Biological evaluation of medical Withdrawn and replaced with
devices—Part 16: Toxicokinetic study design for degradation prod- newer version.
ucts and leachables.
2–172 ................ ........................ ANSI/AAMI/TIR 10993–19:2006 Biological evaluation of medical de- Transferred. See 2–167.
vices—Part 19: Physicochemical, morphological, and topographical
characterization of materials.
2–173 ................ ........................ ANSI/AAMI/ISO 10993–10:2010/(R)2014 Biological evaluation of med- Transferred. See 2–174.
ical devices—Part 10: Tests for irritation and skin sensitization.
2–180 ................ ........................ ANSI/AAMI/ISO 10993–16:2010/(R)2014 Biological evaluation of med- Withdrawn.
ical devices—Part 16: Toxicokinetic study design for degradation
products and leachables from medical devices.
2–181 ................ ........................ ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices Transferred. See 2–205.
for human subjects—Good clinical practice [Including: Technical
Corrigendum 1 (2011)].
2–190 ................ ........................ ANSI/AAMI/ISO 10993–13:2010/(R)2014 Biological evaluation of med- Transferred. See 2–169.
ical devices—Part 13: Identification and quantification of degradation
products from polymeric medical devices.
2–198 ................ ........................ ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical de- Transferred. See 2–191.
vices—Part 12: Sample preparation and reference materials.
2–207 ................ 2–250 ASTM F756–17 Standard Practice for Assessment of Hemolytic Prop- Withdrawn and replaced with
erties of Materials. newer version.
2–221 ................ ........................ ANSI/AAMI/ISO 10993–2:2006 (R2014) Biological evaluation of med- Transferred. See 2–222.
ical devices—Part 2: Animal welfare requirements.
2–226 ................ ........................ ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical de- Transferred. See 2–228.
vices—Part 3: Tests for genotoxicity, carcinogenicity, and reproduc-
tive toxicity.
2–229 ................ 2–251 USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Direct Withdrawn and replaced with
Contact Test. newer version.
2–230 ................ 2–252 USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Elution Withdrawn and replaced with
Test. newer version.
2–231 ................ 2–253 USP 40–NF35:2017 <88> Biological Reactivity Tests, In Vivo .............. Withdrawn and replaced with
newer version.
2–232 ................ 2–254 USP 40–NF35:2017 <151> Pyrogen Test (USP Rabbit Test) ............... Withdrawn and replaced with
newer version. Extent of Rec-
ognition.
2–234 ................ ........................ ANSI/AAMI/ISO 10993–4:2002/(R) 2013 & A1:2006/(R)2013 Biological Withdrawn.
evaluation of medical devices—Part 4: Selection of tests for inter-
action with blood [Including AMENDMENT 1 (2006)].
2–236 ................ ........................ ANSI/AAMI/ISO 10993–17:2002(R) 2012 Biological evaluation of med- Transferred. See 2–237.
ical devices—Part 17: Establishment of allowable limits for leachable
substances.
2–239 ................ ........................ ANSI/AAMI/ISO TIR 10993–20:2006 Biological Evaluation of Medical Transferred. See 2–240.
Devices—Part 20: Principles and methods for immunotoxicology
testing of medical devices.
2–242 ................ ........................ ANSI/AAMI/ISO TIR 37137:2014 Cardiovascular biological evaluation Transferred. See 2–241.
of medical devices—Guidance for absorbable implants.
C. Cardiovascular
3–80 .................. ........................ ANSI/AAMI/ISO 81060–1:2007/(R)2013 Non-invasive sphyg- Transferred. See 3–96.
momanometers—Part 1: Requirements and test methods for non-
automated measurement type.
sradovich on DSK3GMQ082PROD with NOTICES
3–83 .................. ........................ ANSI/AAMI/ISO 14708–5:2010 Implants for surgery—Active Transferred. See 3–92.
implantable medical devices—Part 5: Circulatory support devices.
3–101 ................ ........................ ANSI/AAMI/IEC 60601–2–27:2011 Medical electrical equipment—Part Transferred. See 3–126.
2–27: Particular requirements for the basic safety and essential per-
formance of electrocardiographic monitoring equipment.
3–106 ................ ........................ ANSI/AAMI/IEC 60601–2–25:2011/(R)2016 Medical electrical equip- Transferred. See 3–105.
ment—Part 2–25: Particular requirements for the basic safety and
essential performance of electrocardiographs.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/3.svg)
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26469
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
5–100 ................ ........................ ANSI/AAMI/ISO 80369–20:2015 Small-bore connectors for liquids and Transferred. See 5–97.
gases in healthcare applications—Part 20: Common test methods.
5–118 ................ ........................ ANSI/AAMI/ISO 15223–1:2016 Medical devices—Symbols to be used Transferred. See 5–117.
with medical device labels, labelling and information to be sup-
plied—Part 1: General requirements.
5–119 ................ ........................ ANSI/AAMI/ISO 80369–5:2016 Small-bore connectors for liquids and Transferred. See 5–107.
gases in healthcare applications—Part 5: Connectors for limb cuff
inflation applications.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–2 .................. ........................ ANSI/AAMI/IEC 60601–1–2:2007 (R2012) Medical electrical equip- Transferred. See 19–1.
ment—Part 1–2: General requirements for basic safety and essen-
tial performance—Collateral standard: Electromagnetic compat-
ibility—Requirements and tests.
19–12 ................ ........................ ANSI/AAMI/IEC 60601–1–2:2014 Medical electrical equipment—Part Transferred. See 19–8.
1–2: General requirements for basic safety and essential perform-
ance—Collateral Standard: Electromagnetic disturbances—Require-
ments and tests.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–149 ................ 6–401 ASTM D7160–16 Standard Practice for Determination of Expiration Withdrawn and replaced with
Dating for Medical Gloves. newer version.
6–178 ................ ........................ ASTM D6124–06 (Reapproved 2017) Standard Test Method for Resid- Reaffirmation.
ual Powder on Medical Gloves.
6–214 ................ ........................ ASTM D6355–07 (Reapproved 2017) Standard Test Method for Reaffirmation.
Human Repeat Insult Patch Testing of Medical Glove.
6–217 ................ 6–402 ASTM F1670/F1670M–17 Standard Test Method for Resistance of Withdrawn and replaced with
Materials Used in Protective Clothing to Penetration by Synthetic newer version.
Blood.
6–227 ................ ........................ ANSI/AAMI/IEC 60601–2–21:2009 Medical electrical equipment—Part Transferred. See 6–388.
2–21: Particular requirements for the basic safety and essential per-
formance of infant radiant warmers.
6–229 ................ ........................ ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part Transferred. See 6–389.
2–2: Particular requirements for the basic safety and essential per-
formance of high frequency surgical equipment.
6–232 ................ 6–403 ISO 80601–2–56 Second edition 2017–03 Medical electrical equip- Withdrawn and replaced with
ment—Part 2–56: Particular requirements for basic safety and es- newer version.
sential performance of clinical thermometers for body temperature
measurement.
6–230 ................ ........................ ANSI/AAMI/IEC 60601–2–19:2009 Medical electrical equipment—Part Transferred. See 6–385.
2–19: Particular requirements for the basic safety and essential per-
formance of infant incubators.
6–235 ................ ........................ ANSI/AAMI/IEC 60601–2–50:2009 Medical electrical equipment—Part Transferred. See 6–387.
2–50: Particular requirements for the basic safety and essential per-
formance of infant phototherapy equipment.
6–270 ................ ........................ ASTM F1840–10 (Reapproved 2016) Standard Terminology for Sur- Reaffirmation.
gical Suture Needles.
6–304 ................ 6–404 ISO 7886–1 Second edition 2017–05 Sterile hypodermic syringes for Withdrawn and replaced with
single use—Part 1: Syringes for manual use. newer version.
6–307 ................ 6–405 IEC 80601–2–59 Edition 2.0 2017–09 Medical electrical equipment— Withdrawn and replaced with
Part 2–59: Particular requirements for the basic safety and essential newer version.
performance of screening thermographs for human febrile tempera-
ture screening.
6–323 ................ 6–406 ASTM F1862/F1862M–17 Standard Test Method for Resistance of Withdrawn and replaced with
Medical Face Masks to Penetration by Synthetic Blood (Horizontal newer version.
Projection of Fixed Volume at a Known Velocity).
6–337 ................ ........................ ANSI/AAMI/IEC 60601–2–20:2009 Medical electrical equipment—Part Transferred. See 6–386.
2–20: Particular requirements for the basic safety and essential per-
sradovich on DSK3GMQ082PROD with NOTICES
formance of transport incubators [Including AMENDMENT 1 (2016)].
H. In Vitro Diagnostics (IVD)
7–271 ................ ........................ CLSI M100 27th Edition Performance Standards for Antimicrobial Sus- Extent of recognition.
ceptibility Testing.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/5.svg)
![26470 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
I. Materials
8–113 ................ ........................ ASTM F1147–05 (Reapproved 2017) e1 Standard Test Method for Reaffirmation.
Tension Testing of Calcium Phosphate and Metallic Coatings.
8–337 ................ ........................ ASTM F621–12 (Reapproved 2017) Standard Specification for Stain- Reaffirmation.
less Steel Forgings for Surgical Implants.
8–356 ................ ........................ ASTM F67–13 (Reapproved 2017) Standard Specification for Unal- Reaffirmation.
loyed Titanium, for Surgical Implant Applications (UNS R50250,
UNS R50400, UNS R50550, UNS R50700).
8–446 ................ 8–460 ASTM F2848–17 Standard Specification for Medical-Grade Ultra-High Withdrawn and replaced with
Molecular Weight Polyethylene Yarns. newer version. Extent of recogni-
tion.
J. Nanotechnology
No new entries at this time
K. Neurology
17–1 .................. ........................ ANSI/AAMI NS28:1988/(R)2015 Intracranial pressure monitoring de- Reaffirmation. Extent of recogni-
vices. tion.
17–8 .................. 17–15 ISO 14708–3 Second edition 2017–04 Implants for surgery—Active Withdrawn and replaced with
implantable medical devices—Part 3: Implantable neurostimulators. newer version.
17–10 ................ ........................ ANSI/AAMI/ISO 14708–3:2008/(R)2011 Implants for surgery—Active Withdrawn.
implantable medical devices—Part 3: Implantable neurostimulators.
17–11 ................ 17–16 IEC 60601–2–10 Edition 2.1 2016–04 Medical electrical equipment— Withdrawn and replaced with
Part 2–10: Particular requirements for the basic safety and essential newer version.
performance of nerve and muscle stimulators.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–64 .................. ........................ ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part Withdrawn. Duplicate recognition.
2–2: Particular requirements for the basic safety and essential per- See 6–229.
formance of high frequency surgery equipment and high frequency
surgical accessories.
9–66 .................. ........................ ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and Transferred. See 9–89.
extracorporeal blood circuit for hemodialyzers, hemodiafilters, and
hemofilters.
9–81 .................. ........................ ANSI/AAMI/IEC 60601–2–16:2012 Medical electrical equipment—Part Transferred. See 9–80
2–16: Particular requirements for basic safety and essential perform-
ance of hemodialysis, hemodiafiltration and hemofiltration equipment.
9–91 .................. ........................ ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and Transferred. See 9–92.
extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters,
and hemoconcentrators [Including AMENDMENT 1 (2013)].
9–91 .................. 9–114 IEC 60601–2–18: Edition 3.0 2009–08, medical electrical equipment— Withdrawn and replaced with new
part 2–18: particular requirements for the basic safety and essential recognition number.
performance of endoscopic equipment.
9–93 .................. 9–115 ISO 25841 Third edition 2017–08 Female condoms—Requirements Withdrawn and replaced with
and test methods. newer version.
9–103 ................ ........................ ANSI/AAMI/ISO 26722:2014 Water treatment equipment for Transferred. See 9–101.
haemodialysis applications and related therapies.
9–104 ................ ........................ ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and re- Transferred. See 9–97.
lated therapies.
9–105 ................ ........................ ANSI/AAMI/ISO 13959:2014 Water for hemodialysis and related thera- Transferred. See 9–98.
pies.
9–106 ................ ........................ ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis Transferred. See 9–100.
and related therapies.
9–107 ................ ........................ ANSI/AAMI/ISO 23500:2014 Guidance for the preparation and quality Transferred. See 9–99.
management of fluids for hemodialysis and related therapies.
M. Ophthalmic
sradovich on DSK3GMQ082PROD with NOTICES
10–43 ................ 10–105 ISO 11979–8 Third edition 2017–04 Ophthalmic Implants—Intraocular Withdrawn and replaced with
lenses—Part 8: Fundamental requirements. newer version.
10–46 ................ 10–106 ISO 18369–3 Second edition 2017–08 Ophthalmic optics—Contact Withdrawn and replaced with
lenses—Part 3: Measurement methods. newer version.
10–54 ................ 10–107 ISO 18369–4 Second edition 2017–08 Ophthalmic optics—Contact Withdrawn and replaced with
lenses—Part 4: Physicochemical properties of contact lens materials. newer version.
10–80 ................ 10–108 ISO 18369–2 Third edition 2017–08 Ophthalmic optics—Contact Withdrawn and replaced with
lenses—Part 2: Tolerances. newer version.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/6.svg)
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26471
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
10–83 ................ 10–109 ISO 18369–1 Second edition 2017–08 Ophthalmic optics—Contact Withdrawn and replaced with
lenses—Part 1: Vocabulary, classification system and recommenda- newer version.
tions for labelling specifications.
N. Orthopedic
11–259 .............. ........................ ASTM F2887—12 Standard Specification for Total Elbow Prostheses .. Withdrawn. See 11–321.
O. Physical Medicine
16–200 .............. 16–201 ISO 7176–19 Second edition 2008–07–15 AMENDMENT 1 2015–11– Withdrawn and replaced with a
15. Wheelchairs—Part 19: Wheeled mobility devices for use as newer version including amend-
seats in motor vehicles [Including AMENDMENT 1 (2015)]. ment.
P. Radiology
12–139 .............. ........................ NEMA UD 2–2004 (R2009) Acoustic Output Measurement Standard Withdrawn. Duplicate recognition.
for Diagnostic Ultrasound Equipment, Revision 3. See 12–105.
12–202 .............. 12–308 IEC 60601–2–43 Edition 2.1 2017–05 CONSOLIDATED VERSION Withdrawn and replaced with
Medical electrical equipment—Part 2–43: Particular requirements for newer version.
the safety and essential performance of X-Ray Equipment for inter-
ventional procedures.
12–204 .............. 12–309 IEC 60601–2–28 Edition 3.0 2017–06 Medical electrical equipment— Withdrawn and replaced with
Part 2–28: Particular requirements for the basic safety and essential newer version.
performance of X-ray tube assemblies for medical diagnosis.
12–251 .............. 12–310 IEC 60601–2–63 Edition 1.1 2017–07 CONSOLIDATED VERSION Withdrawn and replaced with
Medical electrical equipment—Part 2–63: Particular requirements for newer version.
the basic safety and essential performance of dental extra-oral X-
Ray equipment.
12–252 .............. 12–311 IEC 60601–2–65 Edition 1.1 2017–05 CONSOLIDATED VERSION Withdrawn and replaced with
Medical electrical equipment—Part 2–65: Particular requirements for newer version.
the basic safety and essential performance of dental intra-oral X-
Ray equipment.
12–227 .............. 12–312 IEC 61391–1 Edition 1.1 2017–07 CONSOLIDATED VERSION Withdrawn and replaced with
Ultrasonics—Pulse-echo scanners—Part 1: Techniques for cali- newer version.
brating spatial measurement systems and measurement of system
point-spread function response.
12–276 .............. 12–313 IEC TS 62462 Edition 2.0 2017–07 Ultrasonics—Output test—Guid- Withdrawn and replaced with
ance for the maintenance of ultrasound physiotherapy systems. newer version.
12–155 .............. 12–314 ISO 11554 Fourth edition 2017–07 Optics and photonics—Lasers and Withdrawn and replaced with
laser-related equipment—Test methods for laser beam power, en- newer version.
ergy and temporal characteristics.
12–192 .............. 12–315 NEMA Standards Publication MS 8–2016 Characterization of the Spe- Withdrawn and replaced with
cific Absorption Rate (SAR) for Magnetic Resonance Imaging Sys- newer version.
tems.
12–258 .............. 12–316 IEC 62359 Edition 2.1 2017–09 CONSOLIDATED VERSION Withdrawn and replaced with
Ultrasonics—Field characterization—Test methods for the deter- newer version.
mination of thermal and mechanical indices related to medical diag-
nostic ultrasonic fields.
Q. Software/Informatics
13–39 ................ ........................ ANSI/AAMI/IEC 80001–1:2010 Application of risk management for IT Transferred. See 13–38.
Networks incorporating medical devices—Part 1: Roles, responsibil-
ities and activities.
13–41 ................ ........................ ANSI/AAMI/IEC TIR80001–2–1:2012 Application of risk management Transferred. See 13–40.
for IT-networks incorporating medical devices—Part 2–1: Step by
step risk management of medical IT-networks; Practical applications
and examples.
13–43 ................ ........................ ANSI/AAMI/IEC TIR80001–2–2:2012 Technical Information Report Ap- Transferred. See 13–42.
sradovich on DSK3GMQ082PROD with NOTICES
plication of risk management for IT-networks incorporating medical
devices—Part 2–2: Guidance for the disclosure and communication
of medical device security needs, risks and controls.
13–45 ................ ........................ ANSI/AAMI/IEC TIR80001–2–3:2012 Technical Information Report Ap- Transferred. See 13–44.
plication of risk management for IT-networks incorporating medical
devices—Part 2–3: Guidance for wireless networks.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/7.svg)
![26472 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
13–64 ................ ........................ ANSI/AAMI/IEC TIR80001–2–4:2012 Technical Information Report Ap- Transferred. See 13–63.
plication of risk management for IT-networks incorporating medical
devices—Part 2–4: General implementation guidance for healthcare
delivery organizations.
R. Sterility
14–221 .............. ........................ ANSI/AAMI/ISO TIR 11139:2006 Sterilization of health care products— Transferred. See 14–325.
Vocabulary.
14–222 .............. ........................ ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care prod- Transferred. See 14–354.
ucts—Biological and chemical indicators—Test equipment.
14–227 .............. ........................ ANSI/AAMI/ISO 11737–1:2006 (R)2011 Sterilization of health care Transferred. See 14–407.
products—Microbiological methods—Part 1: Determination of the
population of microorganisms on product.
14–238 .............. ........................ ANSI/AAMI/ISO 11140–5:2007/(R)2012 Sterilization of health care Transferred. See 14–332.
products—Chemical indicators—Part 5: Class 2 indicators for Bowie
and Dick air removal test sheets and packs.
14–261 .............. ........................ ANSI/AAMI/ISO 17665–1:2006/(R)2013 Sterilization of health care Transferred. See 14–333.
products—Moist heat—Part 1: Requirements for the development,
validation, and routine control of a sterilization process for medical
devices.
14–274 .............. ........................ ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care prod- Transferred. See 14–334.
ucts—Chemical indicators—Guidance for selection, use and inter-
pretation of results.
14–278 .............. ........................ ANSI/AAMI/ISO 10993–7:2008(R)2012 Biological evaluation of med- Transferred. See 14–408.
ical devices—Part 7: Ethylene oxide sterilization residuals.
14–285 .............. ........................ ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care prod- Transferred. See 14–336.
ucts—Biological indicators—Guidance for the selection, use and in-
terpretation of results.
14–287 .............. ........................ ANSI/AAMI/ISO 11737–2:2009/(R)2014 Sterilization of medical de- Transferred. See 14–327.
vices—Microbiological methods—Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization proc-
ess.
14–291 .............. ........................ ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of health care prod- Transferred. See 14–337.
ucts—General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a steri-
lization process for medical devices.
14–295 .............. ........................ ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Infor- Reaffirmation.
mation to be provided by the manufacturer for the processing of
resterilizable medical devices.
14–298 .............. ........................ ANSI/AAMI/ISO 11137–3:2006/(R)2010 Sterilization of health care Withdrawn. See 14–510.
products—Radiation—Part 3: Guidance on dosimetric aspects.
14–330 .............. 14–510 ISO 11137–3 Second edition 2017–06 Sterilization of health care Withdrawn and replaced with
products—Radiation—Part 3: Guidance on dosimetric aspects of de- newer version.
velopment, validation and routine control.
14–339 .............. ........................ ANSI/AAMI/ISO 20857:2010/(R)2015 Sterilization of health care prod- Transferred. See 14–340.
ucts—Dry heat—Requirements for the development, validation and
routine control of a sterilization process for medical devices.
14–348 .............. ........................ ANSI/AAMI/ISO 13408–2:2003/(R)2013 Aseptic processing of health Transferred. See 14–138.
care products—Part 2: Filtration.
14–349 .............. ........................ ANSI/AAMI/ISO 13408–3:2006/(R)2015 Aseptic processing of health Transferred. See 14–239.
care products—Part 3: Lyophilization.
14–350 .............. ........................ ANSI/AAMI/ISO 13408–4:2005/(R)2014 Aseptic processing of health Transferred. See 14–191.
care products—Part 4: Clean-in-place technologies.
14–351 .............. ........................ ANSI/AAMI/ISO 13408–5:2006/(R)2015 Aseptic processing of health Transferred. See 14–240.
care products—Part 5: Sterilization in place.
14–358 .............. ........................ ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care prod- Transferred. See 14–361.
ucts—Liquid chemical sterilizing agents for single-use medical de-
vices utilizing animal tissues and their derivatives—Requirements for
characterization, development, validation and routine control of a
sterilization process for medical devices.
14–376 .............. ........................ ANSI/AAMI/ISO TIR 17665–2:2009 Sterilization of health care prod- Transferred. See 14–277.
sradovich on DSK3GMQ082PROD with NOTICES
ucts—Moist heat—Part 2: Guidance on the application of ANSI/
AAMI/ISO 17665–1.
14–387 .............. ........................ ANSI/AAMI/ISO 13408–7:2012 Aseptic processing of health care prod- Transferred. See 14–388.
ucts—Part 7: Alternative processes for medical devices and com-
bination products.
14–425 .............. ........................ ANSI/AAMI/ISO 13408–6:2005/(R) 2013 & A1:2013 Aseptic proc- Transferred. See 14–424.
essing of health care products—Part 6: Isolator systems [Including
AMENDMENT1 (2013)].
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/8.svg)
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26473
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
14–426 .............. ........................ ANSI/AAMI/ISO 13408–1:2008 (R2011) Aseptic processing of health Transferred. See 14–427.
care products—Part 1: General requirements [Including
AMENDMENT1 (2013)].
14–438 .............. ........................ ANSI/AAMI/ISO 11137–2:2013 Sterilization of health care products— Transferred. See 14–409.
Radiation—Part 2: Establishing the sterilization dose.
14–439 .............. 14–511 ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization Withdrawn and replaced with
and sterility assurance in health care facilities. newer version.
14–457 .............. ........................ ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally steri- Transferred. See 14–454.
lized medical devices—Part 1: Requirements for materials, sterile
barrier systems and packaging [Including AMENDMENT 1 (2013)].
14–458 .............. ........................ ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally steri- Transferred. See 14–455.
lized medical devices—Part 2: Validation requirements for forming,
sealing and assembly processes [Including AMENDMENT 1 (2013)].
14–459 .............. ........................ ANSI/AAMI/ISO 11140–1:2014 Sterilization of health care products— Transferred. See 14–460.
Chemical indicators—Part 1: General requirements.
14–461 .............. ........................ ANSI/AAMI/ISO 11137–1:2006/(R)2010 Sterilization of health care Transferred. See 14–428.
products—Radiation—Part 1: Requirements for development, valida-
tion and routine control of a sterilization process for medical devices
[Including AMENDMENT 1 (2013)].
14–479 .............. ........................ ANSI/AAMI/ISO 11135:2014 Sterilization of health care products— Transferred. See 14–452.
Ethylene oxide—Requirements for development, validation and rou-
tine control of a sterilization process for medical devices.
S. Tissue Engineering
15–17 ................ ........................ ASTM F2311–08 Standard Guide for Classification of Therapeutic Skin Withdrawn.
Substitutes.
15–23 ................ ........................ ASTM F2739–08 Standard Guide for Quantitating Cell Viability within Withdrawn. See 15–50.
Biomaterial Scaffolds.
15–37 ................ 15–51 ASTM F2347–15 Standard Guide for Characterization and Testing of Withdrawn and replaced with
Hyaluronan as Starting Materials Intended for Use in Biomedical newer version.
and Tissue Engineered Medical Product Applications.
15–42 ................ 15–52 ASTM F2064–17 Standard Guide for Characterization and Testing of Withdrawn and replaced with
Alginates as Starting Materials Intended for Use in Biomedical and newer version.
Tissue Engineered Medical Product Applications.
1 All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries added as modifications to the list of
In table 2, FDA provides the listing of recognized standards under Recognition
new entries and consensus standards List Number: 049.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and Date
A. Anesthesiology
1–131 ................. Medical suction equipment—Part 1: Electrically powered suction equipment .......................... ISO 10079–1 Third Edition
2015–11–01.
1–132 ................. Medical suction equipment—Part 2: Manually powered suction equipment ............................ ISO 10079–2 Third Edition
2014–05–01.
1–133 ................. Medical suction equipment—Part 3: Suction equipment powered from a vacuum or positive ISO 10079–3 Third Edition
pressure gas source. 2014–05–01.
1–134 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1: ISO 18562–1 First edition
Evaluation and testing within a risk management process. 2017–03.
1–135 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 2: ISO 18562–2 First edition
Tests for emissions of particulate matter. 2017–03.
1–136 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 3: ISO 18562–3 First edition
sradovich on DSK3GMQ082PROD with NOTICES
Tests for emissions of volatile organic compounds. 2017–03.
1–137 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 4: ISO 18562–4 First edition
Tests for leachables in condensate. 2017–03.
1–138 ................. Medical electrical equipment—Part 2–74: Particular requirements for basic safety and es- ISO 80601–2–74 First edition
sential performance of respiratory humidifying equipment. 2017–05.
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/9.svg)
![26474 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and Date
B. Biocompatibility
No new entries at this time
C. Cardiovascular
No new entries at this time
D. Dental/Ear, Nose, and Throat (ENT)
4–240 ................. Dentistry—Hydrocolloid impression materials ........................................................................... ISO 21563 First edition 2013–
08–15.
4–241 ................. Dental materials—Determination of colour stability .................................................................. ISO 7491 Second edition
2000–09–01.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time
G. General Hospital/General Plastic Surgery (GH/GPS)
6–407 ................. Standard Specification for Adult Portable Bed Rails and Related Products ............................ ASTM F3186–17.
H. In Vitro Diagnostics (IVD)
7–274 ................. Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline ................. CLSI MM17–A Vol. 28 No. 9
(Replaces MM17–P Vol. 27
No. 21).
I. Materials
8–461 ................. Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable ASTM F3208–17.
Medical Devices.
8–462 ................. Standard Test Method for Determining the Flexural Stiffness of Medical Textiles .................. ASTM F3260–17.
8–463 ................. Standard Guide for Additive Manufacturing—General Principles—Requirements for Pur- ISO/ASTM 52901 First edition
chased AM Parts. 2017–08.
8–464 ................. Assessment of the safety of magnetic resonance imaging for patients with an active ISO 10974 Second edition
implantable medical device. 2018.
J. Nanotechnology
18–9 ................... Nanotechnologies—Guidance on physico-chemical characterization of engineered ISO/TR 13014 First edition
nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. 2012–05–15.
18–10 ................. Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus ISO 29701 First edition 2010–
amebocyte lysate (LAL) test. 09–15.
K. Neurology
No new entries at this time
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–115 ................. Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies ISO 29943–1 First edition
based on self-reports. 2017–07.
9–116 ................. Condoms—Guidance on clinical studies—Part 2: Female condoms, clinical function studies ISO 29943–2 First edition
based on self-reports. 2017–07.
M. Ophthalmic
sradovich on DSK3GMQ082PROD with NOTICES
10–110 ............... Ophthalmic implants—Ophthalmic viscosurgical devices [Including AMENDMENT 1 (2017)] ISO 15798 Third edition
2013–09–15 AMENDMENT
1 2017–05.
N. Orthopedic
No new entries at this time
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/10.svg)
![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26475
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and Date
O. Physical Medicine
16–202 ............... RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation ...................... RESNA WC–4:2017.
P. Radiology
No new entries at this time
Q. Software/Informatics
13–104 ............... Software Cybersecurity for Network-Connectable Products, Part 2–1: Particular Require- ANSI/UL 2900–2–1, First Edi-
ments for Network Connectable Components of Healthcare and Wellness Systems. tion September 1, 2017.
R. Sterility
No new entries at this time
S. Tissue Engineering
15–53 ................. Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular ASTM F3206 –17.
Therapies.
15–54 ................. Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fu- ASTM F3207–17.
sion Model.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards DeviceRegulationandGuidance/ treatment of human immunodeficiency
FDA maintains the current list of FDA Standards/ucm123739.htm. virus (HIV).
Recognized Consensus Standards in a Dated: May 31, 2018. DATES: Submit either electronic or
searchable database that may be Leslie Kux, written comments on the guidance
accessed at https:// Associate Commissioner for Policy. August 6, 2018 to ensure that the
www.accessdata.fda.gov/scripts/cdrh/ [FR Doc. 2018–12222 Filed 6–6–18; 8:45 am] Agency considers your comment on this
cfdocs/cfStandards/search.cfm. FDA BILLING CODE 4164–01–P
draft guidance before it begins work on
will be incorporating the modifications the final version of the guidance.
and revisions described in this notice ADDRESSES: You may submit comments
into the database and, upon publication DEPARTMENT OF HEALTH AND on any guidance at any time as follows:
in the Federal Register, this recognition HUMAN SERVICES
of consensus standards will be effective. Electronic Submissions
FDA will be announcing additional Food and Drug Administration Submit electronic comments in the
modifications and revisions to the list of
following way:
recognized consensus standards, as
needed, in the Federal Register once a
[Docket No. FDA–2018–D–1635] • Federal eRulemaking Portal:
year, or more often if necessary. https://www.regulations.gov. Follow the
Prescription Drug User Fee Act
Beginning with recognition list 049, instructions for submitting comments.
Waivers for Fixed-Combination
FDA will no longer include in the Comments submitted electronically,
Antiretroviral Drugs for the President’s
database the CDRH Office and Division including attachments, to https://
Emergency Plan for AIDS Relief; Draft
associated with recognized standards, www.regulations.gov will be posted to
Guidance for Industry; Availability
Devices Affected, and Processes the docket unchanged. Because your
Affected. Beginning with recognition AGENCY: Food and Drug Administration, comment will be made public, you are
list 049 FDA will automatically HHS. solely responsible for ensuring that your
incorporate, upon publication, a U.S. ACTION: Notice of availability. comment does not include any
parallel adoption of an existing confidential information that you or a
recognized international standard. SUMMARY: The Food and Drug third party may not wish to be posted,
Administration (FDA or Agency) is such as medical information, your or
V. Recommendation of Standards for announcing the availability of a draft anyone else’s Social Security number, or
Recognition by FDA guidance for industry entitled confidential business information, such
Any person may recommend ‘‘Prescription Drug User Fee Act as a manufacturing process. Please note
consensus standards as candidates for Waivers for Fixed-Combination that if you include your name, contact
recognition under section 514 of the Antiretroviral Drugs for the President’s information, or other information that
FD&C Act by submitting such Emergency Plan for AIDS Relief.’’ This identifies you in the body of your
sradovich on DSK3GMQ082PROD with NOTICES
recommendations, with reasons for the draft guidance describes circumstances comments, that information will be
recommendation, to under which an applicant may be posted on https://www.regulations.gov.
CDRHStandardsStaff@fda.hhs.gov. To eligible for a barrier-to-innovation • If you want to submit a comment
be considered, such recommendations waiver for some new drug applications with confidential information that you
should contain, at a minimum, the (NDAs) for fixed-combination versions do not wish to be made available to the
following information available at and single-entity versions of previously public, submit the comment as a
https://www.fda.gov/MedicalDevices/ approved antiretroviral therapies for the written/paper submission and in the
VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1](https://thefederalregister.org/doc/83_FR_26575/page/11.svg)
Document Created: 2018-06-07 00:50:43
Document Modified: 2018-06-07 00:50:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | These modifications to the list of recognized standards are applicable June 7, 2018. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected] | |
| FR Citation | 83 FR 26465 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR