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
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 |