81 FR 41546 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 043
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 123 (June 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 123 (June 27, 2016)
| Page Range | 41546-41553 | |
| FR Document | 2016-15100 |
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)] [Notices] [Pages 41546-41553] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15100] ----------------------------------------------------------------------- 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: 043 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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: 043'' (Recognition List Number: 043), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective June 27, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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: 043.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday [[Page 41547]] 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: 043. 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 043 is available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 043 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: 043'' to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847- 8149. FOR FURTHER INFORMATION CONTACT: Scott A. 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 (the 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 a notice published in the Federal Register 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. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at http://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. Both versions are publicly accessible at the Agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 043 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term ``Recognition List Number: 043'' to identify these 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. Anesthesia ---------------------------------------------------------------------------------------------------------------- 1-91........................... 1-116 ISO 5360 Fourth edition 2016-02- Withdrawn and replaced with 15 Anaesthetic vaporizers--Agent newer version. specific filling systems. ---------------------------------------------------------------------------------------------------------------- B. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-135.......................... .............. ISO/TS 12417-1:2011 Withdrawn. Cardiovascular implants and extracorporeal systems--Vascular device-drug combination products. [[Page 41548]] 3-136.......................... .............. AAMI/ANSI/ISO TIR 12417:2011 Withdrawn. Cardiovascular implants and extracorporeal systems--Vascular device-drug combination products. ---------------------------------------------------------------------------------------------------------------- C. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- 4-86........................... .............. ANSI/ADA 38-2000 (R2015) Metal- Reaffirmation. Ceramic Systems. 4-139.......................... .............. ANSI/ADA 48-2004 (R2015) Visible Reaffirmation. Light Curing Units. 4-146.......................... 4-227 ISO 22674 Second edition. 2016-01- Withdrawn and replaced with 15 Dentistry--Metallic materials newer version. for fixed and removable restorations and appliances. 4-166.......................... 4-228 ANSI/ASA S3.20-2015 (Revision of Withdrawn and replaced with ANSI S3.20-1995) AMERICAN newer version. NATIONAL STANDARD: Bioacoustical Terminology. 4-196.......................... .............. ANSI/ADA 69-2010 (R2015) Dental Reaffirmation. Ceramics. 4-202.......................... .............. ANSI/ADA 58-2010 (R2015) Root Reaffirmation. Canal Files, Type H (Hedstrom). ---------------------------------------------------------------------------------------------------------------- D. General I (Quality Systems/Risk Management) (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-36........................... .............. ISO TR 16142 Second edition. 2006- Withdrawn. See 5-105. 1-15, Technical information report: Medical devices-- Guidances on the selection of standards in support of recognized essential principles of safety and performance of medical devices. 5-40........................... .............. ISO 14971 Second edition. 2007-03- Relevant guidance. 01 Medical devices--Application of risk management to medical devices. 5-57........................... .............. AAMI/ANSI HE75:2009/(R)2013 Human Relevant guidance. factors engineering--Design of medical devices. 5-67........................... .............. AAMI/ANSI/IEC 62366:2007/(R) 2013 Transition period. Medical devices--Application of usability engineering to medical devices. 5-70........................... .............. AAMI/ANSI/ISO 14971:2007/(R) 2010 Relevant guidance. (Corrected 4 October 2007) Medical devices--Application of risk management to medical devices. 5-86........................... .............. IEC 60601-1-8 Edition 2.0. 2006- Relevant guidance. 10 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. 5-87........................... .............. IEC 62366 Edition 1.1 2014-01 Transition period. Medical devices--Application of usability engineering to medical devices. 5-89........................... .............. IEC 60601-1-6 Edition 3.1 2013-10 Relevant guidance. Medical electrical equipment-- Part 1-6: General requirements for basic safety and essential performance--Collateral standard: Usability. 5-92........................... .............. AAMI/ANSI/IEC 60601-1-8:2006 & Relevant guidance. 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. 5-93........................... .............. AAMI CN3:2014 Small-bore Withdrawn. See 5-106. connectors for liquids and gases in healthcare applications--Part 3: Connectors for enteral applications. 5-95........................... .............. IEC 62366-1 Edition 1.0 2015-02 Transition period, Relevant Medical devices--Part 1: guidance. Application of usability engineering to medical devices. 5-96........................... .............. AAMI/ANSI/IEC 62366-1:2015 Transition period, Relevant Medical devices--Part 1: guidance. Application of usability engineering to medical devices. 5-101.......................... .............. AAMI CN6:2015 Small-bore Withdrawn. See 5-108. connectors for liquids and gases in healthcare applications--Part 6: Connectors for neuraxial applications. ---------------------------------------------------------------------------------------------------------------- E. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ---------------------------------------------------------------------------------------------------------------- 19-1........................... .............. IEC 60601-1-2 Edition 3. 2007-03, Transition period. Medical electrical equipment-- Part 1-2: General requirements for basic safety and essential performance--Collateral standard: Electromagnetic compatibility--Requirements and tests. 19-2........................... .............. AAMI/ANSI/IEC 60601-1-2:2007/ Transition period. (R)2012 Medical electrical equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic compatibility-- Requirements and tests. 19-6........................... .............. IEC 60601-1-11 Edition 1.0. 2010- Relevant guidance. 04 Medical electrical equipment-- Part 1-11: General requirements for basic safety and essential performance--Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [including: Technical Corrigendum 1 (2011)]. [[Page 41549]] 19-7........................... .............. AAMI/ANSI HA 60601-1-11:2011 Relevant guidance. Medical electrical equipment-- Part 1-11: General requirements for basic safety and essential performance--Collateral standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010 Mod). 19-8........................... .............. IEC 60601-1-2 Edition 4.0. 2014- Transition period. 02, Medical electrical equipment--Part 1-2: General requirements for basic safety and essential performance-- Collateral standard: Electromagnetic disturbances-- Requirements and tests. 19-12.......................... .............. AAMI/ANSI/IEC 60601-1-2:2014, Transition period. Medical electrical equipment-- Part 1-2: General requirements for basic safety and essential performance--Collateral standard: Electromagnetic disturbances--Requirements and tests. 19-14.......................... .............. IEC 60601-1-11 Edition 2.0. 2015- Relevant guidance. 01 Medical electrical equipment-- Part 1-11: General requirements for basic safety and essential performance--Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. 19-15.......................... .............. IEC 60601-1-12 Edition 1.0. 2014- Relevant guidance. 06 Medical electrical equipment-- Part 1-12: General requirements for basic safety and essential performance--Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. ---------------------------------------------------------------------------------------------------------------- F. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-15........................... 6-362 ISO/FDIS 7864 Fourth edition 2016- Withdrawn and replaced with XX-XX Sterile hypodermic needles newer version. for single use--Requirements and test methods. 6-132.......................... 6-363 ISO 11810 Second edition 2015-12- Withdrawn and replaced with 15 Lasers and laser-related newer version. equipment--Test method and classification for the laser resistance of surgical drapes and/or patient protective covers--Primary ignition, penetration, flame spread and secondary ignition. 6-145.......................... .............. ASTM D3578--05 (Reapproved 2015) Reaffirmation. Standard Specification for Rubber Examination Gloves. 6-168.......................... .............. ASTM D3577--09 (Reapproved 2015) Reaffirmation. Standard Specification for Rubber Surgical Gloves. 6-175.......................... .............. ASTM D5151--06 (Reapproved 2015) Reaffirmation. Standard Test Method for Detection of Holes in Medical Gloves. 6-183.......................... .............. ASTM D5250--06 (Reapproved 2015) Reaffirmation. Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. 6-202.......................... .............. ISO 11810-2 First edition. 2007- Withdrawn. See 6-362. 05-01, Lasers and laser-related equipment--Test method and classification for the laser- resistance of surgical drapes and/or patient-protective covers--Part 2: Secondary ignition. 6-204.......................... 6-364 ISO 8537 Third edition. 2016-03- Withdrawn and replaced with 15 Sterile single-use syringes, newer version. with or without needle, for insulin. 6-244.......................... .............. ASTM D6319--10 (Reapproved 2015) Reaffirmation. Standard Specification for Nitrile Examination Gloves for Medical Application. 6-277.......................... 6-365 ISO 11040-4 Third edition. 2015- Withdrawn and replaced with 04-01 Prefilled syringes--Part newer version. 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling. 6-302.......................... 6-366 ISO/FDIS 9626 Second edition 2016- Withdrawn and replaced with XX-XX Stainless steel needle newer version. tubing for the manufacture of medical devices--Requirements and test methods. 6-343.......................... 6-367 USP 39-NF 34:2016, Sodium Withdrawn and replaced with Chloride Irrigation. newer version. 6-344.......................... 6-368 USP 39-NF 34:2016, Sodium Withdrawn and replaced with Chloride Injection. newer version. 6-345.......................... 6-369 USP 39-NF 34:2016, Nonabsorbable Withdrawn and replaced with Surgical Suture. newer version. 6-346.......................... 6-370 USP 39-NF 34:2016, <881> Tensile Withdrawn and replaced with Strength. newer version. 6-347.......................... 6-371 USP 39-NF 34:2016, <861> Sutures-- Withdrawn and replaced with Diameter. newer version. 6-348.......................... 6-372 USP 39-NF 34:2016, <871> Sutures-- Withdrawn and replaced with Needle Attachment. newer version. 6-349.......................... 6-373 USP 39-NF 34:2016, Sterile Water Withdrawn and replaced with for Irrigation. newer version. [[Page 41550]] 6-350.......................... 6-374 USP 39-NF 34:2016, Heparin Lock Withdrawn and replaced with Flush Solution. newer version. 6-351.......................... 6-375 USP 39-NF 34:2016, Absorbable Withdrawn and replaced with Surgical Suture. newer version. ---------------------------------------------------------------------------------------------------------------- G. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-198.......................... 7-261 CLSI M23 Development of In Vitro Withdrawn and replaced with Susceptibility Testing Criteria newer version. and Quality Control Parameters, 4th edition. 7-218.......................... 7-262 CLSI M45 Methods for Withdrawn and replaced with Antimicrobial Dilution and Disk newer version. Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline, 3rd edition. 7-256.......................... 7-263 CLSI M100-S26 Performance Withdrawn and replaced with Standards for Antimicrobial newer version. Susceptibility Testing, 26th edition. ---------------------------------------------------------------------------------------------------------------- H. Materials ---------------------------------------------------------------------------------------------------------------- 8-217.......................... .............. ASTM F620-11(Reapproved 2015) Reaffirmation. Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition. 8-220.......................... 8-421 ASTM F629-11 Standard Practice Withdrawn and replaced with for Radiography of Cast Metallic newer version. Surgical Implants. 8-381.......................... 8-422 ASTM F2052-15 Standard Test Withdrawn and replaced with Method for Measurement of newer version. Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. ---------------------------------------------------------------------------------------------------------------- I. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-168......................... 11-305 ASTM F1781-15 Standard Withdrawn and replaced with Specification for Elastomeric newer version. Flexible Hinge Finger Total Joint Implants. 11-171......................... 11-306 ASTM F1814-15 Standard Guide for Withdrawn and replaced with Evaluating Modular Hip and Knee newer version. Joint Components. 11-203......................... .............. ASTM F1541-02 (Reapproved 2015) Reaffirmation. Standard Specification and Test Methods for External Skeletal Fixation Devices. 11-271......................... .............. ASTM F2180-02 (Reapproved 2015) Reaffirmation. Standard Specification for Metallic Implantable Strands and Cables. ---------------------------------------------------------------------------------------------------------------- J. Radiology ---------------------------------------------------------------------------------------------------------------- 12-153......................... 12-297 ANSI/IESNA RP-27.1-15 Recommended Withdrawn and replaced with Practice for Photobiological newer version. Safety for Lamps and Lamp Systems--General requirements. 12-158......................... 12-298 NEMA MS 10-2010 Determination of Withdrawn and replaced with Local Specific Absorption Rate newer version. (SAR) in Diagnostic Magnetic Resonance Imaging. 12-207......................... .............. IEC 60601-2-33 Ed. 3.0 2010 Transition period extended. Medical electrical equipment-- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 12-209......................... .............. IEC 60601-2-37 Ed. 2.0:2007 Recognition restored with Medical electrical equipment-- transition period. Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. 12-216......................... 12-299 IEC 62563-1 Ed.1.1 2016 Medical Withdrawn and replaced with electrical equipment--Medical newer version with image display systems--Part 1: transition. Evaluation methods. 12-236......................... .............. IEC 60601-2-45 Ed. 3.0: 2011 Recognition restored with Medical electrical equipment-- transition period. Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. 12-238......................... 12-300 NEMA Digital Imaging and Withdrawn and replaced with Communications in Medicine newer version. (DICOM) set PS3.1-3.20 (2016). 12-254......................... 12-301 IEC 60601-2-8 Ed. 2.1 b:2015 Withdrawn and replaced with Medical electrical equipment-- newer version. Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV. 12-256......................... .............. IEC 60601-2-44 Ed. 3.1 2012 Transition extended. Medical electrical equipment-- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. 12-257......................... .............. IEC 60601-2-44 Ed. 3.0 2009 Transition extended. Medical electrical equipment-- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. 12-271......................... .............. IEC 60601-2-33 Ed. 3.1:2013 Recognition restored with Medical electrical equipment-- transition period. Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. [[Page 41551]] 12-274......................... .............. IEC 60601-2-54 Ed. 1.0:2009 Recognition restored with Medical electrical equipment-- transition period. Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Technical Corrigendum 1: 2010 and Technical Corrigendum 2:2011]. 12-293......................... .............. IEC 60601-2-37 Ed. 2.1:2015 Transition period. Medical electrical equipment-- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. 12-294......................... .............. IEC 60601-2-45 Ed. 3.1: 2015 Transition period. Medical electrical equipment-- Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. 12-295......................... .............. IEC 60601-2-33 Ed. 3.2 b:2015 Transition period extended. Medical electrical equipment-- Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. 12-296......................... .............. IEC 60601-2-54 Ed. 1.1:2015 Transition period. Medical electrical equipment-- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. ---------------------------------------------------------------------------------------------------------------- K. Sterility ---------------------------------------------------------------------------------------------------------------- 14-139......................... 14-479 ISO 14644-1 Second edition 2015- Withdrawn and replaced with 12-15 Cleanrooms and associated newer version. controlled environments--Part 1: Classification of air cleanliness by particle concentration. 14-140......................... 14-481 ISO 14644-2 Second edition 2015- Withdrawn and replaced with 12-15 Cleanrooms and associated newer version. controlled environments--Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. 14-283......................... 14-482 ASTM F88/F88M--15 Standard Test Withdrawn and replaced with Method for Seal Strength of newer version. Flexible Barrier Materials. 14-341......................... 14-483 ISO/ASTM 52303 First edition 2015- Withdrawn and replaced with 07-15 Guide for absorbed-dose newer version. mapping in radiation processing facilities. 14-344......................... .............. ASTM F2825--10 (Reapproved 2015) Reaffirmation. Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery. 14-378......................... 14-484 ASTM F1929--15 Standard Test Withdrawn and replaced with Method for Detecting Seal Leaks newer version. in Porous Medical Packaging by Dye Penetration. 14-466......................... 14-485 USP 39-NF34:2016 <61> Withdrawn and replaced with Microbiological Examination of newer version. Nonsterile Products: Microbial Enumeration Tests. 14-467......................... 14-486 USP 39-NF34:2016 <71> Sterility Withdrawn and replaced with Tests. newer version. 14-468......................... 14-487 USP 39-NF34:2016 <85> Bacterial Withdrawn and replaced with Endotoxins Test. newer version. 14-469......................... 14-488 USP 39-NF34:2016 <161> Medical Withdrawn and replaced with Devices-Bacterial Endotoxin and newer version. Pyrogen Tests. 14-470......................... 14-489 USP 39-NF34:2016 Biological Withdrawn and replaced with Indicator for Steam newer version. Sterilization, Self Contained. 14-471......................... 14-490 USP 39-NF34:2016 Biological Withdrawn and replaced with Indicator for Dry-Heat newer version. Sterilization, Paper Carrier. 14-472......................... 14-491 USP 39-NF34:2016 Biological Withdrawn and replaced with Indicator for Ethylene Oxide newer version. Sterilization, Paper Carrier. 14-473......................... 14-492 USP 39-NF34:2016 Biological Withdrawn and replaced with Indicator for Steam newer version. Sterilization, Paper Carrier. 14-474......................... 14-493 USP 39-NF34:2016 <62> Withdrawn and replaced with Microbiological Examination of newer version. Nonsterile Products: Tests for Specified Microorganisms. 14-475......................... 14-494 USP 39-NF34:2016 <55> Biological Withdrawn and replaced with Indicators--Resistance newer version. Performance Tests. 14-476......................... 14-495 USP 39-NF34:2016 <1035> Withdrawn and replaced with Biological Indicators for newer version. Sterilization. ---------------------------------------------------------------------------------------------------------------- \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: 043. [[Page 41552]] Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and date ------------------------------------------------------------------------ A. Cardiovascular ------------------------------------------------------------------------ 3-142......................... Cardiovascular ISO/TS implants and 17137:2014. extracorporeal systems--Cardiovascul ar absorbable implants. 3-143......................... Cardiovascular ISO 12417 First implants and edition 2015-10- extracorporeal 01. systems--Vascular device-drug combination products. ------------------------------------------------------------------------ B. General I (Quality Systems/Risk Management) (QS/RM) ------------------------------------------------------------------------ 5-105......................... Medical devices-- ISO 16142-1 Recognized essential First edition principles of safety 2016-03-01. and performance of medical devices--Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards. 5-106......................... Small-bore connectors ISO/FDIS 80369-3 for liquids and gases First edition in healthcare 2016-02-04. applications--Part 3: Connectors for enteral applications. 5-107......................... Small-bore connectors IEC 80369-5: for liquids and gases Edition 1.0 in healthcare 2016-03. applications--Part 5: Connectors for limb cuff inflation applications. 5-108......................... Small bore connectors ISO 80369-6 for liquids and gases First edition. in healthcare 2016-03-15. applications--Part 6: Connectors for neuraxial applications. ------------------------------------------------------------------------ C. General Hospital/General Plastic Surgery (GH/GPS) ------------------------------------------------------------------------ 6-376......................... Hypodermic needles for ISO/FDIS 6009 single use--Colour Fourth edition coding for 2016-01-18. identification. 6-377......................... Needle-based injection ISO 11608-5 systems for medical First edition use--Requirements and 2012-10-01. test methods--Part 5: Automated functions. 6-378......................... Needle-based injection ISO/FDIS 11608-7 systems for medical First edition use--Requirements and 2016-06-16. test methods--Part 7: Accessibility for persons with visual impairment. ------------------------------------------------------------------------ D. In Vitro Diagnostic ------------------------------------------------------------------------ 7-264......................... Genomic Copy Number MM21- Ed. 1. Microarrays for Constitutional Genetic and Oncology Applications, 1st edition. ------------------------------------------------------------------------ E. Materials ------------------------------------------------------------------------ 8-423......................... Standard Guide for ASTM F2565-13. Extensively Irradiation- Crosslinked Ultra- High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications. 8-424......................... Standard Specification ASTM F2695-12. for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha- Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications. 8-425......................... Standard Specification ASTM F2820-12. for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications. 8-426......................... Standard Specification ASTM F3087-15. for Acrylic Molding Resins for Medical Implant Applications. 8-427......................... Standard Specification ASTM F1185-03 for Composition of (Reapproved Hydroxylapatite for 2014). Surgical Implants. 8-428......................... Standard Specification ASTM F1581-08 for Composition of (Reapproved Anorganic Bone for 2012). Surgical Implants. 8-429......................... Standard Specification ASTM F2224-09 for High Purity (Reapproved Calcium Sulfate 2014). Hemihydrate or Dihydrate for Surgical Implants. 8-430......................... Implants for surgery-- ISO 13356:2015 Ceramic materials Third edition. based on yttria- 2015-09-15. stabilized tetragonal zirconia (Y-TZP). 8-431......................... Standard Practice for ASTM F2971-13. Reporting Data for Test Specimens Prepared by Additive Manufacturing. 8-432......................... Standard Terminology ISO/ASTM 52921- for Additive 13 First Manufacturing- edition 2013-06- Coordinate Systems 01. and Test Methodologies. 8-434......................... Additive ISO/ASTM 52900 manufacturing--Genera First edition l principles-- 2015-12-15. Terminology. ------------------------------------------------------------------------ F. Orthopedic ------------------------------------------------------------------------ 11-307........................ Standard Practice for ASTM F2385-15. Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs. 11-308........................ Standard Test Method ASTM F3161-16. for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions. 11-309........................ Standard Specification ASTM F116-12. for Medical Screwdriver Bits. 11-310........................ Standard Specification ASTM F1611-00 for Intramedullary (Reapproved Reamers. 2013). ------------------------------------------------------------------------ G. Radiology ------------------------------------------------------------------------ 12-302........................ Medical electrical IEC 60601-2-44 equipment--Part 2-44: Ed. 3.2:2016. Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. ------------------------------------------------------------------------ [[Page 41553]] H. Software/Informatics ------------------------------------------------------------------------ 13-82......................... Application of risk AAMI/ISO TIR management for IT 80001-2-6:2014. networks incorporating medical--Application guidance--Part 2-6: Guidance for responsibility agreements. 13-83......................... Principles for medical AAMI TIR device security--Risk 57:2016. management. 13-84......................... Health informatics-- ISO/IEEE 11073- Point-of-care medical 10103 First device communication-- edition 2014-03- Part 10103: 01. Nomenclature--Implant able device, cardiac. ------------------------------------------------------------------------ I. Tissue Engineering ------------------------------------------------------------------------ 15-45......................... Medical devices ISO 22442-1 utilizing animal Second edition tissues and their 2015-11-1. derivatives--Part 1: Application of risk management. 15-46......................... Medical devices ISO 22442-2 utilizing animal Second edition tissues and their 2015-11-1. derivatives--Part 2: Controls on sourcing, collection and handling. 15-47......................... Medical devices ISO 22442-3 utilizing animal First edition tissues and their 2007-12-15. derivatives--Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate 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 announce 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 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. 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 properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ``Guidance on the Recognition and Use of Consensus Standards'' by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the Federal Register, this notice announcing ``Modification to the List of Recognized Standards, Recognition List Number: 043'' will be available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition and Use of Consensus Standards,'' and the searchable database for ``FDA Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards. Dated: June 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15100 Filed 6-24-16; 8:45 am] BILLING CODE 4164-01-P
![41546 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices
for the 21st Century—A Risk Based of the applicable statutes and DATES: Submit electronic or written
Approach’’ in 2004,1 CDER has regulations. comments concerning this document at
continued to promote its vision of a any time. These modifications to the list
II. Paperwork Reduction Act of 1995
maximally efficient, agile, flexible of recognized standards are effective
manufacturing sector that reliably This guide refers to previously June 27, 2016.
produces high-quality drug products approved collections of information that ADDRESSES: You may submit comments
without extensive regulatory oversight. are subject to review by the Office of as follows:
The draft guidance for industry on Management and Budget under the
‘‘Request for Quality Metrics’’ and this Paperwork Reduction Act of 1995 (44 Electronic Submissions
technical reference document continues U.S.C. 3501–3520). Relevant to this Submit electronic comments in the
the outreach policy of FDA so as to collection of information, FDA following way:
ensure successful implementation of published a document entitled ‘‘Request • Federal eRulemaking Portal: http://
CDER’s objectives outlined in the 21st for Quality Metrics; Notice of Draft www.regulations.gov. Follow the
Century publication. The objectives of Guidance and Public Meeting; Request instructions for submitting comments.
CDER’s metric program can best be for Comments’’ in the Federal Register Comments submitted electronically,
achieved through collaboration and of July 28, 2015 (80 FR 44973). In including attachments, to http://
mutual recognition of standards for Section IV, ‘‘Paperwork Reduction Act www.regulations.gov will be posted to
metric indicators and data exchange/ of 1995,’’ FDA estimated the burden that the docket unchanged. Because your
reporting. would cover the use of technical comment will be made public, you are
The purpose of this Guide is to standards discussed in this draft guide. solely responsible for ensuring that your
provide technical recommendations for comment does not include any
III. Electronic Access confidential information that you or a
the submission of quality metric data. It
is intended to ensure clear expectations Persons with access to the Internet third party may not wish to be posted,
for industry on the submission of may obtain the draft guide at either such as medical information, your or
quality metric data as described in the http://www.fda.gov/Drugs/Guidance anyone else’s Social Security number, or
‘‘Request for Quality Metrics’’ draft ComplianceRegulatoryInformation/ confidential business information, such
guidance. We note that the comment Guidances/default.htm, http:// as a manufacturing process. Please note
period for that draft guidance closed in www.fda.gov/BiologicsBloodVaccines/ that if you include your name, contact
November 2015 and that the comments GuidanceCompliance information, or other information that
that were received are undergoing RegulatoryInformation/default.htm or identifies you in the body of your
evaluation. This Guide is intended to be http://www.regulations.gov. comments, that information will be
a companion document to the July 28, Dated: June 21, 2016. posted on http://www.regulations.gov.
2015, draft guidance. There may be • If you want to submit a comment
Leslie Kux,
modifications to the draft guidance and with confidential information that you
Associate Commissioner for Policy. do not wish to be made available to the
this guide based on our evaluation of [FR Doc. 2016–15099 Filed 6–24–16; 8:45 am]
the submitted comments. Our goal is to public, submit the comment as a
institute efficient regulatory review,
BILLING CODE 4164–01–P written/paper submission and in the
compliance oversight, and inspection manner detailed (see ‘‘Written/Paper
policies established on risk-based Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
methods, including quality metric HUMAN SERVICES Written/Paper Submissions
reporting. This Guide is intended to Submit written/paper submissions as
facilitate collaboration between industry Food and Drug Administration follows:
and FDA regarding the best • Mail/Hand delivery/Courier (for
methodologies to address all issues of [Docket No. FDA–2004–N–0451]
written/paper submissions): Division of
implementation. Due to the inherent Dockets Management (HFA–305), Food
variability among reporting Food and Drug Administration
Modernization Act of 1997: and Drug Administration, 5630 Fishers
establishments’ implementation of the Lane, rm. 1061, Rockville, MD 20852.
process validation lifecycle and PQS Modifications to the List of Recognized
Standards, Recognition List Number: • For written/paper comments
assessment, it is difficult to identify and submitted to the Division of Dockets
compare quality issues between firms. 043
Management, FDA will post your
As such, FDA recognizes the importance AGENCY: Food and Drug Administration, comment, as well as any attachments,
of industry input and agreement HHS. except for information submitted,
regarding standardized indicators of marked and identified, as confidential,
ACTION: Notice.
manufacturing and product quality. if submitted as detailed in
This guide is being issued consistent SUMMARY: The Food and Drug ‘‘Instructions.’’
with FDA’s good guidance practices Administration (FDA) is announcing a Instructions: All submissions received
regulation (21 CFR 10.115). The current publication containing modifications must include the Docket No. FDA–
version of the guide will represent the the Agency is making to the list of 2004–N–0451 for ‘‘Food and Drug
current thinking of FDA on this topic. standards FDA recognizes for use in Administration Modernization Act of
It does not establish any rights for any premarket reviews (FDA Recognized 1997: Modifications to the List of
person and is not binding on FDA or the Consensus Standards). This publication, Recognized Standards, Recognition List
mstockstill on DSK3G9T082PROD with NOTICES
public. You can use an alternative entitled ‘‘Modifications to the List of Number: 043.’’ Received comments will
approach if it satisfies the requirements Recognized Standards, Recognition List be placed in the docket and, except for
Number: 043’’ (Recognition List those submitted as ‘‘Confidential
1 http://www.fda.gov/Drugs/Development
Number: 043), will assist manufacturers Submissions,’’ publicly viewable at
ApprovalProcess/Manufacturing/Questionsand
AnswersonCurrentGoodManufacturing
who elect to declare conformity with http://www.regulations.gov or at the
PracticescGMPforDrugs/ucm137175.htm (Fall 2004) consensus standards to meet certain Division of Dockets Management
(last visited: March 17, 2016). requirements for medical devices. between 9 a.m. and 4 p.m., Monday
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![41548 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition Title of standard 1 Change
recognition No. No.
3–136 ............. ........................ AAMI/ANSI/ISO TIR 12417:2011 Cardiovascular implants and Withdrawn.
extracorporeal systems—Vascular device-drug combination products.
C. Dental/Ear, Nose, and Throat (ENT)
4–86 ............... ........................ ANSI/ADA 38–2000 (R2015) Metal-Ceramic Systems ............................. Reaffirmation.
4–139 ............. ........................ ANSI/ADA 48–2004 (R2015) Visible Light Curing Units .......................... Reaffirmation.
4–146 ............. 4–227 ISO 22674 Second edition. 2016–01–15 Dentistry—Metallic materials Withdrawn and replaced with newer
for fixed and removable restorations and appliances. version.
4–166 ............. 4–228 ANSI/ASA S3.20–2015 (Revision of ANSI S3.20–1995) AMERICAN Withdrawn and replaced with newer
NATIONAL STANDARD: Bioacoustical Terminology. version.
4–196 ............. ........................ ANSI/ADA 69–2010 (R2015) Dental Ceramics ........................................ Reaffirmation.
4–202 ............. ........................ ANSI/ADA 58–2010 (R2015) Root Canal Files, Type H (Hedstrom) ....... Reaffirmation.
D. General I (Quality Systems/Risk Management) (QS/RM)
5–36 ............... ........................ ISO TR 16142 Second edition. 2006–1–15, Technical information re- Withdrawn. See 5–105.
port: Medical devices—Guidances on the selection of standards in
support of recognized essential principles of safety and performance
of medical devices.
5–40 ............... ........................ ISO 14971 Second edition. 2007–03–01 Medical devices—Application Relevant guidance.
of risk management to medical devices.
5–57 ............... ........................ AAMI/ANSI HE75:2009/(R)2013 Human factors engineering—Design of Relevant guidance.
medical devices.
5–67 ............... ........................ AAMI/ANSI/IEC 62366:2007/(R) 2013 Medical devices—Application of Transition period.
usability engineering to medical devices.
5–70 ............... ........................ AAMI/ANSI/ISO 14971:2007/(R) 2010 (Corrected 4 October 2007) Med- Relevant guidance.
ical devices—Application of risk management to medical devices.
5–86 ............... ........................ IEC 60601–1–8 Edition 2.0. 2006–10 Medical electrical equipment— Relevant guidance.
Part 1–8: General requirements for basic safety and essential per-
formance—Collateral standard: General requirements, tests and guid-
ance for alarm systems in medical electrical equipment and medical
electrical systems.
5–87 ............... ........................ IEC 62366 Edition 1.1 2014–01 Medical devices—Application of Transition period.
usability engineering to medical devices.
5–89 ............... ........................ IEC 60601–1–6 Edition 3.1 2013–10 Medical electrical equipment—Part Relevant guidance.
1–6: General requirements for basic safety and essential perform-
ance—Collateral standard: Usability.
5–92 ............... ........................ AAMI/ANSI/IEC 60601–1–8:2006 & A1:2012 Medical electrical equip- Relevant guidance.
ment—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 med-
ical electrical systems.
5–93 ............... ........................ AAMI CN3:2014 Small-bore connectors for liquids and gases in Withdrawn. See 5–106.
healthcare applications—Part 3: Connectors for enteral applications.
5–95 ............... ........................ IEC 62366–1 Edition 1.0 2015–02 Medical devices—Part 1: Application Transition period, Relevant guid-
of usability engineering to medical devices. ance.
5–96 ............... ........................ AAMI/ANSI/IEC 62366–1:2015 Medical devices—Part 1: Application of Transition period, Relevant guid-
usability engineering to medical devices. ance.
5–101 ............. ........................ AAMI CN6:2015 Small-bore connectors for liquids and gases in Withdrawn. See 5–108.
healthcare applications—Part 6: Connectors for neuraxial applications.
E. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–1 ............... ........................ IEC 60601–1–2 Edition 3. 2007–03, Medical electrical equipment—Part Transition period.
1–2: General requirements for basic safety and essential perform-
ance—Collateral standard: Electromagnetic compatibility—Require-
ments and tests.
19–2 ............... ........................ AAMI/ANSI/IEC 60601–1–2:2007/(R)2012 Medical electrical equip- Transition period.
ment—Part 1–2: General requirements for basic safety and essential
mstockstill on DSK3G9T082PROD with NOTICES
performance—Collateral standard: Electromagnetic compatibility—Re-
quirements and tests.
19–6 ............... ........................ IEC 60601–1–11 Edition 1.0. 2010–04 Medical electrical equipment— Relevant guidance.
Part 1–11: General requirements for basic safety and essential per-
formance—Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment [including: Technical Corrigendum 1 (2011)].
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![Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices 41551
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition Title of standard 1 Change
recognition No. No.
12–274 ........... ........................ IEC 60601–2–54 Ed. 1.0:2009 Medical electrical equipment—Part 2– Recognition restored with transition
54: Particular requirements for the basic safety and essential per- period.
formance of X-ray equipment for radiography and radioscopy [Includ-
ing: Technical Corrigendum 1: 2010 and Technical Corrigendum
2:2011].
12–293 ........... ........................ IEC 60601–2–37 Ed. 2.1:2015 Medical electrical equipment—Part 2– Transition period.
37: Particular requirements for the basic safety and essential per-
formance of ultrasonic medical diagnostic and monitoring equipment.
12–294 ........... ........................ IEC 60601–2–45 Ed. 3.1: 2015 Medical electrical equipment—Part 2– Transition period.
45: Particular requirements for the basic safety and essential per-
formance of mammographic X-ray equipment and mammographic
stereotactic devices.
12–295 ........... ........................ IEC 60601–2–33 Ed. 3.2 b:2015 Medical electrical equipment—Part 2– Transition period extended.
33: Particular requirements for the basic safety and essential per-
formance of magnetic resonance equipment for medical diagnosis.
12–296 ........... ........................ IEC 60601–2–54 Ed. 1.1:2015 Medical electrical equipment—Part 2– Transition period.
54: Particular requirements for the basic safety and essential per-
formance of X-ray equipment for radiography and radioscopy.
K. Sterility
14–139 ........... 14–479 ISO 14644–1 Second edition 2015–12–15 Cleanrooms and associated Withdrawn and replaced with newer
controlled environments—Part 1: Classification of air cleanliness by version.
particle concentration.
14–140 ........... 14–481 ISO 14644–2 Second edition 2015–12–15 Cleanrooms and associated Withdrawn and replaced with newer
controlled environments—Part 2: Monitoring to provide evidence of version.
cleanroom performance related to air cleanliness by particle con-
centration.
14–283 ........... 14–482 ASTM F88/F88M—15 Standard Test Method for Seal Strength of Flexi- Withdrawn and replaced with newer
ble Barrier Materials. version.
14–341 ........... 14–483 ISO/ASTM 52303 First edition 2015–07–15 Guide for absorbed-dose Withdrawn and replaced with newer
mapping in radiation processing facilities. version.
14–344 ........... ........................ ASTM F2825—10 (Reapproved 2015) Standard Practice for Climatic Reaffirmation.
Stressing of Packaging Systems for Single Parcel Delivery.
14–378 ........... 14–484 ASTM F1929—15 Standard Test Method for Detecting Seal Leaks in Withdrawn and replaced with newer
Porous Medical Packaging by Dye Penetration. version.
14–466 ........... 14–485 USP 39–NF34:2016 <61> Microbiological Examination of Nonsterile Withdrawn and replaced with newer
Products: Microbial Enumeration Tests. version.
14–467 ........... 14–486 USP 39–NF34:2016 <71> Sterility Tests .................................................. Withdrawn and replaced with newer
version.
14–468 ........... 14–487 USP 39–NF34:2016 <85> Bacterial Endotoxins Test .............................. Withdrawn and replaced with newer
version.
14–469 ........... 14–488 USP 39–NF34:2016 <161> Medical Devices-Bacterial Endotoxin and Withdrawn and replaced with newer
Pyrogen Tests. version.
14–470 ........... 14–489 USP 39–NF34:2016 Biological Indicator for Steam Sterilization, Self Withdrawn and replaced with newer
Contained. version.
14–471 ........... 14–490 USP 39–NF34:2016 Biological Indicator for Dry-Heat Sterilization, Withdrawn and replaced with newer
Paper Carrier. version.
14–472 ........... 14–491 USP 39–NF34:2016 Biological Indicator for Ethylene Oxide Sterilization, Withdrawn and replaced with newer
Paper Carrier. version.
14–473 ........... 14–492 USP 39–NF34:2016 Biological Indicator for Steam Sterilization, Paper Withdrawn and replaced with newer
Carrier. version.
14–474 ........... 14–493 USP 39–NF34:2016 <62> Microbiological Examination of Nonsterile Withdrawn and replaced with newer
Products: Tests for Specified Microorganisms. version.
14–475 ........... 14–494 USP 39–NF34:2016 <55> Biological Indicators—Resistance Perform- Withdrawn and replaced with newer
ance Tests. version.
14–476 ........... 14–495 USP 39–NF34:2016 <1035> Biological Indicators for Sterilization .......... Withdrawn and replaced with newer
version.
1 All standard titles in this table conform to the style requirements of the respective organizations.
mstockstill on DSK3G9T082PROD with NOTICES
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: 043.
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![Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Notices 41553
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No. Title of standard 1 Reference No. and date
H. Software/Informatics
13–82 ...................... Application of risk management for IT networks incorporating medical—Applica- AAMI/ISO TIR 80001–2–6:2014.
tion guidance—Part 2–6: Guidance for responsibility agreements.
13–83 ...................... Principles for medical device security—Risk management ................................... AAMI TIR 57:2016.
13–84 ...................... Health informatics—Point-of-care medical device communication—Part 10103: ISO/IEEE 11073–10103 First edition
Nomenclature—Implantable device, cardiac. 2014–03–01.
I. Tissue Engineering
15–45 ...................... Medical devices utilizing animal tissues and their derivatives—Part 1: Applica- ISO 22442–1 Second edition 2015–11–
tion of risk management. 1.
15–46 ...................... Medical devices utilizing animal tissues and their derivatives—Part 2: Controls ISO 22442–2 Second edition 2015–11–
on sourcing, collection and handling. 1.
15–47 ...................... Medical devices utilizing animal tissues and their derivatives—Part 3: Validation ISO 22442–3 First edition 2007–12–15.
of the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards identification of the testing or DEPARTMENT OF HEALTH AND
FDA maintains the Agency’s current performance or other characteristics of HUMAN SERVICES
list of FDA Recognized Consensus the device(s) that would be addressed
Standards in a searchable database that by a declaration of conformity. Food and Drug Administration
may be accessed directly at FDA’s VI. Electronic Access [Docket No. FDA–2013–D–1170]
Internet site at http://
www.accessdata.fda.gov/scripts/cdrh/ You may obtain a copy of ‘‘Guidance Chronic Hepatitis C Virus Infection:
cfdocs/cfStandards/search.cfm. FDA on the Recognition and Use of Developing Direct-Acting Antiviral
will incorporate the modifications and Consensus Standards’’ by using the Drugs for Treatment; Draft Guidance
revisions described in this notice into Internet. The Center for Devices and for Industry; Extension of the
the database and, upon publication in Radiological Health (CDRH) maintains a Comment Period
the Federal Register, this recognition of site on the Internet for easy access to
consensus standards will be effective. AGENCY: Food and Drug Administration,
information including text, graphics, HHS.
FDA will announce additional
and files that you may download to a Notice; extension of the
ACTION:
modifications and revisions to the list of
personal computer with access to the comment period.
recognized consensus standards, as
needed, in the Federal Register once a Internet. Updated on a regular basis, the
CDRH home page, http://www.fda.gov/ SUMMARY: The Food and Drug
year, or more often if necessary.
MedicalDevices, includes a link to Administration (FDA or we) is
Beginning with Recognition List 033,
standards-related documents including extending the comment period for the
FDA no longer announces minor
the guidance and the current list of notice of availability, published in the
revisions to the list of recognized
recognized standards. After publication Federal Register of May 4, 2016 (81 FR
consensus standards such as technical
in the Federal Register, this notice 26805), announcing the draft guidance
contact person, devices affected,
announcing ‘‘Modification to the List of for industry entitled ‘‘Chronic Hepatitis
processes affected, Code of Federal
Recognized Standards, Recognition List C Virus Infection: Developing Direct-
Regulations citations, and product
Number: 043’’ will be available at http:// Acting Antiviral Drugs for Treatment.’’
codes.
We are taking this action due to
www.fda.gov/MedicalDevices/
V. Recommendation of Standards for maintenance on the Federal
DeviceRegulationandGuidance/
Recognition by FDA eRulemaking portal from July 1 through
Standards/ucm123792.htm. You may July 5, 2016.
Any person may recommend access ‘‘Guidance on the Recognition
consensus standards as candidates for DATES: Submit either electronic or
and Use of Consensus Standards,’’ and
recognition under section 514 of the written comments by July 19, 2016.
the searchable database for ‘‘FDA
FD&C Act by submitting such Recognized Consensus Standards’’ at ADDRESSES: You may submit comments
recommendations, with reasons for the as follows:
http://www.fda.gov/MedicalDevices/
recommendation, to standards@
DeviceRegulationandGuidance/ Electronic Submissions
cdrh.fda.gov. To be properly considered,
Standards.
such recommendations should contain, Submit electronic comments in the
at a minimum, the following Dated: June 21, 2016. following way:
information: (1) Title of the standard, (2) Leslie Kux, • Federal eRulemaking Portal: http://
mstockstill on DSK3G9T082PROD with NOTICES
any reference number and date, (3) Associate Commissioner for Policy. www.regulations.gov. Follow the
name and address of the national or [FR Doc. 2016–15100 Filed 6–24–16; 8:45 am]
instructions for submitting comments.
international standards development Comments submitted electronically,
BILLING CODE 4164–01–P
organization, (4) a proposed list of including attachments, to http://
devices for which a declaration of www.regulations.gov will be posted to
conformity to this standard should the docket unchanged. Because your
routinely apply, and (5) a brief comment will be made public, you are
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Document Created: 2016-06-25 02:07:19
Document Modified: 2016-06-25 02:07:19
| 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 | Submit electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective June 27, 2016. | |
| Contact | Scott A. 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 | 81 FR 41546 |
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