81 FR 94388 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 046
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 247 (December 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 247 (December 23, 2016)
| Page Range | 94388-94394 | |
| FR Document | 2016-31008 |
[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)] [Notices] [Pages 94388-94394] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31008] ----------------------------------------------------------------------- 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: 046 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: 046'' (Recognition List Number: 046), 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 December 23, 2016. 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): 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: 046.'' 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 Division of Dockets Management 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: 046. 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 https://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: 046 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: 046 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: 046'' 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, 301-796-6287. 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 (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 [[Page 94389]] 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: 046 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: 046'' 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. Anesthesiology ---------------------------------------------------------------------------------------------------------------- 1-44............................. 1-117 ISO 5366 First edition 2016-10- Withdrawn and replaced with 01 Anaesthetic and respiratory newer version. equipment--Tracheostomy tubes and connectors. 1-93............................. 1-118 ISO 5361 Third edition 2016-09- Withdrawn and replaced with 01 Anaesthetic and respiratory newer version. equipment--Tracheal tubes and connectors. ---------------------------------------------------------------------------------------------------------------- B. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-93............................. .............. ASTM F763-04 (Reapproved 2016) Reaffirmation. Standard Practice for Short- Term Screening of Implant Materials. 2-94............................. .............. ASTM F981-04 (Reapproved 2016) Reaffirmation. Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone. 2-126............................ 2-244 ASTM F748-16 Standard Practice Withdrawn and replaced with for Selecting Generic newer version, Extent of Biological Test Methods for recognition. Materials and Devices. 2-134............................ .............. ASTM F2065-00 (Reapproved 2010) Withdrawn. Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials. 2-189............................ .............. ASTM F895-11 (Reapproved 2016) Reaffirmation. Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. 2-225............................ .............. ASTM F2567-06 (Reapproved 2010) Withdrawn. Standard Practice for Testing for Classical Complement Activation in Serum by Solid Materials. ---------------------------------------------------------------------------------------------------------------- C. Cardiovascular ---------------------------------------------------------------------------------------------------------------- 3-58............................. .............. ANSI/AAMI/ISO 5840:2005/(R)2010 Withdrawn. Cardiovascular implants-- Cardiac valve prostheses. 3-90............................. 3-144 ISO 7198 Second edition 2016-08- Withdrawn and replaced with 01 Cardiovascular implants and newer version. extracorporeal systems-- Vascular prostheses--Tubular vascular grafts and vascular patches. 3-91............................. .............. ISO 5840 Fourth edition 2005-03- Withdrawn. 01 Cardiovascular implants-- Cardiac valve prostheses. ---------------------------------------------------------------------------------------------------------------- D. Dental/Ear, Nose, and Throat (ENT) ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- E. General I (Quality Systems/Risk Management) (QS/RM) ---------------------------------------------------------------------------------------------------------------- 5-79............................. 5-113 ASTM D7386-16 Standard Practice Withdrawn and replaced with for Performance Testing of newer version. Packages for Single Parcel Delivery Systems. 5-87............................. .............. IEC 62366 Edition 1.1 2014-01 Transition. Consolidated Version Medical devices--Application of usability engineering to medical devices. [[Page 94390]] 5-95............................. 5-114 IEC 62366-1 Edition 1.0 2015-02 Withdrawn and replaced with Medical Devices--Part 1: newer version including Application of Usability corrigendum. Engineering to Medical Devices [Including CORRIGENDUM 1 (2016)]. ---------------------------------------------------------------------------------------------------------------- F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- G. General Hospital/General Plastic Surgery (GH/GPS) ---------------------------------------------------------------------------------------------------------------- 6-11............................. .............. ISO 594-1 First edition 1986-06- Transition. 15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment--Part 1: General requirements. 6-129............................ .............. ISO 594-2 Second edition 1998-09- Transition. 01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment--Part 2: Lock fittings. 6-165............................ .............. ASTM D6977-04 (Reapproved 2016) Reaffirmation. Standard Specification for Polychloroprene Examination Gloves for Medical Application. 6-282............................ 6-383 ASTM D6499-16 Standard Test Withdrawn and replaced with Method for The Immunological newer version. Measurement of Antigenic Protein in Natural Rubber and its Products. ---------------------------------------------------------------------------------------------------------------- H. In Vitro Diagnostics (IVD) ---------------------------------------------------------------------------------------------------------------- 7-149............................ 7-267 CLSI C24 4th Edition Statistical Withdrawn and replaced with Quality Control for newer version. Quantitative Measurement Procedures: Principles and Definitions. 7-174............................ 7-268 CLSI EP21 2nd Edition Evaluation Withdrawn and replaced with of Total Analytical Error for newer version, Extent of Quantitative Medical Laboratory recognition. Measurement Procedures. ---------------------------------------------------------------------------------------------------------------- I. Materials ---------------------------------------------------------------------------------------------------------------- 8-350............................ 8-435 ISO 5832-1 Fifth edition 2016-07- Withdrawn and replaced with 15 Implants for surgery-- newer version. Metallic materials--Part 1: Wrought stainless steel. 8-368............................ .............. ASTM F2625-10 (Reapproved 2016) Reaffirmation. Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High- Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry. 8-376............................ .............. ASTM F2102-13 Standard Guide for Withdrawn. See 8-382. Evaluating the Extent of Oxidation in Ultra-High- Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants. 8-384............................ 8-436 ASTM F2026-16 Standard Withdrawn and replaced with Specification for newer version. Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. 8-392............................ 8-437 ASTM F2082/F2082M-16 Standard Withdrawn and replaced with Test Method for Determination newer version. of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery. 8-407............................ 8-438 ISO/ASTM 52915 Second edition Withdrawn and replaced with 2016-02-15 Specification for newer version. Additive Manufacturing File Format (AMF) Version 1.2. ---------------------------------------------------------------------------------------------------------------- J. Nanotechnology ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- K. Neurology ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- M. Ophthalmic ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- N. Orthopedic ---------------------------------------------------------------------------------------------------------------- 11-223........................... 11-311 ISO 14243-2 Third edition 2016- Withdrawn and replaced with 09-01 Implants for surgery-- newer version. Wear of total knee-joint prostheses--Part 2: Methods of measurement. [[Page 94391]] 11-225........................... 11-312 ISO 7206-4 Third edition 2010-06- Withdrawn and replaced with 15 Implants for surgery-- newer version including Components for partial and amendment. total knee joint prostheses-- Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016)]. 11-231........................... 11-313 ISO 7207-2 Second edition 2011- Withdrawn and replaced with 07-01 Implants for surgery-- newer version including Components for partial and amendment. total knee joint prostheses-- Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016)]. 11-249........................... 11-314 ISO 14242-2 Second edition 2016- Withdrawn and replaced with 09-15 Implants for surgery-- newer version. Wear of total hip-joint prostheses--Part 2: Methods of measurement. 11-268........................... 11-315 ASTM F1829-16 Standard Test Withdrawn and replaced with Method for Static Evaluation of newer version. Anatomic Glenoid Locking Mechanism in Shear. 11-287........................... .............. ASTM F382-14 Standard Withdrawn. See 11-297. Specification and Test Method for Metallic Bone Plates. 11-298........................... 11-316 ASTM F1264-16 Standard Withdrawn and replaced with Specification and Test Methods newer version. for Intramedullary Fixation Devices. ---------------------------------------------------------------------------------------------------------------- O. Physical Medicine ---------------------------------------------------------------------------------------------------------------- .............. No modifications at this time ........................... ---------------------------------------------------------------------------------------------------------------- P. Radiology ---------------------------------------------------------------------------------------------------------------- 12-49............................ 12-303 IEC 61303 Edition 1.0 1994-09 Withdrawn and replaced with Medical electrical equipment-- new version including Radionuclide calibrators-- corrigendum. Particular methods for describing performance [Including CORRIGENDUM 1 (2016)]. 12-235........................... 12-304 IEC 60731 Edition 3.1 2016-04 Withdrawn and replaced with Consolidated Version Medical newer version. electrical equipment-- Dosimeters with ionization chambers as used in radiotherapy. 12-263........................... 12-305 ISO 13694 Second edition 2015-11- Withdrawn and replaced with 15 Optics and Photonics--Lasers newer version. and laser-related equipment-- Test methods for laser beam power (energy) density distribution. ---------------------------------------------------------------------------------------------------------------- Q. Software/Informatics ---------------------------------------------------------------------------------------------------------------- 13-27............................ 13-85 CLSI AUTO11-A2 October 2014 Withdrawn and replaced with Information Technology Security newer version. of In Vitro Diagnostic Instruments and Software Systems; Approved Standard-- Second Edition. ---------------------------------------------------------------------------------------------------------------- R. Sterility ---------------------------------------------------------------------------------------------------------------- 14-169........................... .............. ASTM F2391-05 (Reapproved 2016) Reaffirmation. Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas. 14-197........................... 14-496 ASTM F1608-16 Standard Test Withdrawn and replaced with Method for Microbial Ranking of newer version. Porous Packaging Materials (Exposure Chamber Method). 14-229........................... 14-497 ASTM F1980-16 Standard Guide for Withdrawn and replaced with Accelerated Aging of Sterile newer version. Barrier Systems for Medical Devices. 14-285........................... .............. ANSI/AAMI/ISO 14161-2009/(R)2014 Reaffirmation. Sterilization of health care products--Biological indicators--Guidance for the selection, use and interpretation of results. 14-311........................... .............. ANSI/AAMI ST55:2010/(R)2014 Reaffirmation. Table-top steam sterilizers. 14-339........................... .............. ANSI/AAMI/ISO 20857:2010/(R)2015 Reaffirmation. (Revision of ANSI/AAMI/ ST63:2002) Sterilization of health care products--Dry heat-- Requirements for the development, validation and routine control of a sterilization process for medical devices. 14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Reaffirmation. (R)2015 Aseptic processing of health care products--Part 3: Lyophilization. 14-360........................... .............. ANSI/AAMI ST72:2011/(R)2016 Reaffirmation. Bacterial endotoxins--Test methods, routine monitoring, and alternatives to batch testing. 14-453........................... 14-498 ASTM F2097-16 Standard Guide for Withdrawn and replaced with Design and Evaluation of newer version. Primary Flexible Packaging for Medical Products. 14-462........................... 14-499 ASTM D4169-16 Standard Practice Withdrawn and replaced with for Performance Testing of newer version. Shipping Containers and Systems. 14-479........................... 14-500 ISO 14644-1 Second edition 2015- Withdrawn and replaced with 12-15 Cleanrooms and associated new recognition number. controlled environments--Part 1: Classification of air cleanliness by particle concentration. 14-489........................... .............. USP 39-NF34:2016 Biological Withdrawn. Indicator for Steam Sterilization--Self Contained. 14-490........................... .............. USP 39-NF34:2016 Biological Withdrawn. Indicator for Dry-Heat Sterilization, Paper Carrier. [[Page 94392]] 14-491........................... .............. USP 39-NF34:2016 Biological Withdrawn. Indicator for Ethylene Oxide Sterilization, Paper Carrier. 14-492........................... .............. USP 39-NF34:2016 Biological Withdrawn. Indicator for Steam Sterilization, Paper Carrier. ---------------------------------------------------------------------------------------------------------------- S. Tissue Engineering ---------------------------------------------------------------------------------------------------------------- 15-34............................ 15-48 ASTM F2605-16 Standard Test Withdrawn and replaced with Method for Determining the newer version. Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC- MALS). ---------------------------------------------------------------------------------------------------------------- \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: 046. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. and Recognition No. Title of standard \1\ date ------------------------------------------------------------------------ A. Anesthesiology ------------------------------------------------------------------------ 1-119.................... Tracheal tubes designed ISO 14408 Third for laser surgery-- edition 2016-02- Requirements for 15. marking and accompanying information. 1-120.................... Anaesthetic and ISO 18190 First respiratory equipment-- edition 2016-11- General requirements 01. for airways and related equipment. ------------------------------------------------------------------------ B. Biocompatibility ------------------------------------------------------------------------ 2-245.................... Biological evaluation of ISO 10993-5 Third medical devices--Part edition 2009-06- 5: Tests for in vitro 01. cytotoxicity. ------------------------------------------------------------------------ C. Cardiovascular ------------------------------------------------------------------------ 3-145.................... Cardiovascular implants-- ISO 5840-1:2015 Cardiac valve First edition 2015- prostheses--Part 1: 09-15. General requirements. 3-146.................... Cardiovascular implants-- ANSI/AAMI/ISO 5840- Cardiac valve 1: 2015. prostheses--Part 1: General requirements. 3-147.................... Cardiovascular implants-- ISO 5840-2: 2015 Cardiac valve First edition 2015- prostheses--Part 2: 09-15. Surgically implanted heart valve substitutes. 3-148.................... Cardiovascular implants-- ANSI/AAMI/ISO 5840- Cardiac valve 2: 2015. prostheses -- Part 2: Surgically implanted heart valve substitutes. ------------------------------------------------------------------------ D. Dental/Ear, Nose, and Throat (ENT) ------------------------------------------------------------------------ 4-229.................... Medical electrical IEC 80601-2-60 equipment--Part 2-60: Edition 1.0 2012- Particular requirements 02. for the basic safety and essential performance of dental equipment. ------------------------------------------------------------------------ E. General I (Quality Systems/Risk Management) (QS/RM) ------------------------------------------------------------------------ 5-115.................... Small-bore connectors ISO 80369-7 First for liquids and gases edition 2016-10- in healthcare 15. applications--Part 7: Connectors for intravascular or hypodermic applications. 5-116.................... Graphical symbols-- ISO 7010 Second Safety colours and edition 2011-06- safety signs-- 01. Registered safety signs [Including AMENDMENT 1 (2012) through AMENDMENT 7 (2016)]. ------------------------------------------------------------------------ F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) ------------------------------------------------------------------------ 19-19.................... Medical electrical IEC TR 60601-4-2 equipment--Part 4-2: Edition 1.0 2016- Guidance and 05. interpretation--Electro magnetic immunity: Performance of medical electrical equipment and medical electrical systems. 19-20.................... American National ANSI C63.16-2016 Standard Guide for (Revision of ANSI Electrostatic Discharge C63.16-1993). Test Methodologies and Acceptance Criteria for Electronic Equipment. 19-21.................... Medical Electrical AIM Standard Rev. Equipment and System 1.00 2016-08-22. Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers-- An AIM Standard. ------------------------------------------------------------------------ G. General Hospital/General Plastic Surgery (GH/GPS) ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ [[Page 94393]] H. In Vitro Diagnostics (IVD) ------------------------------------------------------------------------ 7-269.................... Molecular Diagnostic CLSI MM23 1st Methods for Solid Edition. Tumors (Nonhematological Neoplasms). ------------------------------------------------------------------------ I. Materials ------------------------------------------------------------------------ 8-439.................... Standard Specification ASTM F3001-14. for Additive Manufacturing Titanium- 6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. 8-440.................... Standard Specification ASTM F3091/F3091M- for Powder Bed Fusion 14. of Plastic Materials. 8-441.................... Standard Test Method for ASTM F3109-16. Verification of Multi- Axis Force Measuring Platforms. 8-442.................... Standard Guide for ASTM F3127-16. Validating Cleaning Processes Used During the Manufacture of Medical Devices. 8-443.................... Standard Guide for ASTM F3160-16. Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants. 8-444.................... Additive manufacturing-- ISO 17296-2 First General principles-- edition 2015-01- Part 2: Overview of 15. process categories and feedstock. 8-445.................... Additive manufacturing-- ISO 17296-4 First General principles-- edition 2014-09- Part 4: Overview of 01. data processing. 8-446.................... Standard Specification ASTM F2848-16. for Medical-Grade Ultra- High Molecular Weight Polyethylene Yarns. ------------------------------------------------------------------------ J. Nanotechnology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ K. Neurology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ M. Ophthalmic ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ N. Orthopedic ------------------------------------------------------------------------ 11-317................... Standard Guide for ASTM F3129--16. Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses. 11-318................... Standard Guide for Total ASTM F3141--15. Knee Replacement Loading Profiles. 11-319................... Implants for surgery-- ISO 7206-12 First Partial and total hip edition 2016-10- joint prostheses--Part 01. 12: Deformation test method for acetabular shells. 11-320................... Implants for surgery-- ISO 7206-13 First Partial and total hip edition 2016-07- joint prostheses--Part 01. 13: Determination of resistance to torque of head fixation of stemmed femoral components.. ------------------------------------------------------------------------ O. Physical Medicine ------------------------------------------------------------------------ 16-199................... Wheelchairs Part 28: ISO 7176-28 First Requirements and test edition 2012-10-1. methods for stairclimbing devices. ------------------------------------------------------------------------ P. Radiology ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ Q. Software/Informatics ------------------------------------------------------------------------ 13-86.................... Systems and software ISO/IEC 15026-1 engineering--Systems First edition 2013- and software assurance-- 11-01. Part 1: Concepts and vocabulary. 13-87.................... Systems and software ISO/IEC 15026-2 engineering--Systems First edition 2011- and software assurance-- 02-15. Part 2: Assurance case. ------------------------------------------------------------------------ R. Sterility ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ S. Tissue Engineering ------------------------------------------------------------------------ No new entries at this time. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. [[Page 94394]] 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: 046'' 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: December 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31008 Filed 12-22-16; 8:45 am] BILLING CODE 4164-01-P
![94388 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
Dated: December 19, 2016. comments, that information will be sheet and not in the body of your
Leslie Kux, posted on https://www.regulations.gov. comments and you must identify this
Associate Commissioner for Policy. • If you want to submit a comment information as ‘‘confidential.’’ Any
[FR Doc. 2016–30966 Filed 12–22–16; 8:45 am] with confidential information that you information marked as ‘‘confidential’’
BILLING CODE 4164–01–P
do not wish to be made available to the will not be disclosed except in
public, submit the comment as a accordance with 21 CFR 10.20 and other
written/paper submission and in the applicable disclosure law. For more
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper information about FDA’s posting of
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). comments to public dockets, see 80 FR
Written/Paper Submissions 56469, September 18, 2015, or access
Food and Drug Administration the information at: http://www.fda.gov/
Submit written/paper submissions as regulatoryinformation/dockets/
[Docket No. FDA–2004–N–0451] follows: default.htm.
• Mail/Hand delivery/Courier (for Docket: For access to the docket to
Food and Drug Administration written/paper submissions): Division of
Modernization Act of 1997: read background documents or the
Dockets Management (HFA–305), Food electronic and written/paper comments
Modifications to the List of Recognized and Drug Administration, 5630 Fishers
Standards, Recognition List Number: received, go to https://
Lane, Rm. 1061, Rockville, MD 20852. www.regulations.gov and insert the
046 • For written/paper comments
docket number, found in brackets in the
submitted to the Division of Dockets
AGENCY: Food and Drug Administration, heading of this document, into the
Management, FDA will post your
HHS. ‘‘Search’’ box and follow the prompts
comment, as well as any attachments,
ACTION: Notice. and/or go to the Division of Dockets
except for information submitted,
Management, 5630 Fishers Lane, Rm.
marked and identified, as confidential,
SUMMARY: The Food and Drug 1061, Rockville, MD 20852.
if submitted as detailed in
Administration (FDA or Agency) is An electronic copy of Recognition List
‘‘Instructions.’’
announcing a publication containing Instructions: All submissions received Number: 046 is available on the Internet
modifications the Agency is making to must include the Docket No. FDA– at http://www.fda.gov/MedicalDevices/
the list of standards FDA recognizes for 2004–N–0451 for ‘‘Food and Drug DeviceRegulationandGuidance/
use in premarket reviews (FDA Administration Modernization Act of Standards/ucm123792.htm. See section
Recognized Consensus Standards). This 1997: Modifications to the List of VI of this document for electronic access
publication, entitled ‘‘Modifications to Recognized Standards, Recognition List to the searchable database for the
the List of Recognized Standards, Number: 046.’’ Received comments will current list of FDA recognized
Recognition List Number: 046’’ be placed in the docket and, except for consensus standards, including
(Recognition List Number: 046), will those submitted as ‘‘Confidential Recognition List Number: 046
assist manufacturers who elect to Submissions,’’ publicly viewable at modifications and other standards
declare conformity with consensus https://www.regulations.gov or at the related information. Submit written
standards to meet certain requirements Division of Dockets Management requests for a single hard copy of the
for medical devices. between 9 a.m. and 4 p.m., Monday document entitled ‘‘Modifications to the
DATES: Submit electronic or written through Friday. FDA will consider any List of Recognized Standards,
comments concerning this document at comments received in determining Recognition List Number: 046’’ to Scott
any time. These modifications to the list whether to amend the current listing of Colburn, Center for Devices and
of recognized standards are effective modifications to the list of recognized Radiological Health, Food and Drug
December 23, 2016. standards, Recognition List Number: Administration, 10903 New Hampshire
ADDRESSES: You may submit comments 046. Ave., Bldg. 66, Rm. 5514, Silver Spring,
as follows: • Confidential Submissions—To MD 20993, 301–796–6287. Send one
submit a comment with confidential self-addressed adhesive label to assist
Electronic Submissions information that you do not wish to be that office in processing your request, or
Submit electronic comments in the made publicly available, submit your fax your request to 301–847–8144.
following way: comments only as a written/paper FOR FURTHER INFORMATION CONTACT:
• Federal eRulemaking Portal: https:// submission. You should submit two Scott Colburn, Center for Devices and
www.regulations.gov. Follow the copies total. One copy will include the Radiological Health, Food and Drug
instructions for submitting comments. information you claim to be confidential Administration, 10903 New Hampshire
Comments submitted electronically, with a heading or cover note that states Ave., Bldg. 66, Rm. 5514, Silver Spring,
including attachments, to https:// ‘‘THIS DOCUMENT CONTAINS MD 20993, 301–796–6287, standards@
www.regulations.gov will be posted to CONFIDENTIAL INFORMATION.’’ The cdrh.fda.gov.
the docket unchanged. Because your Agency will review this copy, including SUPPLEMENTARY INFORMATION:
comment will be made public, you are the claimed confidential information, in
solely responsible for ensuring that your its consideration of comments. The I. Background
comment does not include any second copy, which will have the Section 204 of the Food and Drug
confidential information that you or a claimed confidential information Administration Modernization Act of
third party may not wish to be posted, redacted/blacked out, will be available 1997 (FDAMA) (Pub. L. 105–115)
mstockstill on DSK3G9T082PROD with NOTICES
such as medical information, your or for public viewing and posted on http:// amended section 514 of the Federal
anyone else’s Social Security number, or www.regulations.gov. Submit both Food, Drug, and Cosmetic Act (the
confidential business information, such copies to the Division of Dockets FD&C Act) (21 U.S.C. 360d). Amended
as a manufacturing process. Please note Management. If you do not wish your section 514 allows FDA to recognize
that if you include your name, contact name and contact information to be consensus standards developed by
information, or other information that made publicly available, you can international and national organizations
identifies you in the body of your provide this information on the cover for use in satisfying portions of device
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![94390 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
5–95 .................. 5–114 IEC 62366–1 Edition 1.0 2015–02 Medical Devices—Part 1: Applica- Withdrawn and replaced with
tion of Usability Engineering to Medical Devices [Including CORRI- newer version including corri-
GENDUM 1 (2016)]. gendum.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No modifications at this time
G. General Hospital/General Plastic Surgery (GH/GPS)
6–11 .................. ........................ ISO 594–1 First edition 1986–06–15 Conical fittings with a 6% (Luer) Transition.
taper for syringes, needles and certain other medical equipment—
Part 1: General requirements.
6–129 ................ ........................ ISO 594–2 Second edition 1998–09–01 Conical fittings with a 6% Transition.
(Luer) taper for syringes, needles and certain other medical equip-
ment—Part 2: Lock fittings.
6–165 ................ ........................ ASTM D6977–04 (Reapproved 2016) Standard Specification for Reaffirmation.
Polychloroprene Examination Gloves for Medical Application.
6–282 ................ 6–383 ASTM D6499–16 Standard Test Method for The Immunological Meas- Withdrawn and replaced with
urement of Antigenic Protein in Natural Rubber and its Products. newer version.
H. In Vitro Diagnostics (IVD)
7–149 ................ 7–267 CLSI C24 4th Edition Statistical Quality Control for Quantitative Meas- Withdrawn and replaced with
urement Procedures: Principles and Definitions. newer version.
7–174 ................ 7–268 CLSI EP21 2nd Edition Evaluation of Total Analytical Error for Quan- Withdrawn and replaced with
titative Medical Laboratory Measurement Procedures. newer version, Extent of recogni-
tion.
I. Materials
8–350 ................ 8–435 ISO 5832–1 Fifth edition 2016–07–15 Implants for surgery—Metallic Withdrawn and replaced with
materials—Part 1: Wrought stainless steel. newer version.
8–368 ................ ........................ ASTM F2625–10 (Reapproved 2016) Standard Test Method for Meas- Reaffirmation.
urement of Enthalpy of Fusion, Percent Crystallinity, and Melting
Point of Ultra-High-Molecular Weight Polyethylene by Means of Dif-
ferential Scanning Calorimetry.
8–376 ................ ........................ ASTM F2102–13 Standard Guide for Evaluating the Extent of Oxida- Withdrawn. See 8–382.
tion in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms
Intended for Surgical Implants.
8–384 ................ 8–436 ASTM F2026–16 Standard Specification for Polyetheretherketone Withdrawn and replaced with
(PEEK) Polymers for Surgical Implant Applications. newer version.
8–392 ................ 8–437 ASTM F2082/F2082M–16 Standard Test Method for Determination of Withdrawn and replaced with
Transformation Temperature of Nickel-Titanium Shape Memory Al- newer version.
loys by Bend and Free Recovery.
8–407 ................ 8–438 ISO/ASTM 52915 Second edition 2016–02–15 Specification for Addi- Withdrawn and replaced with
tive Manufacturing File Format (AMF) Version 1.2. newer version.
J. Nanotechnology
No modifications at this time
K. Neurology
No modifications at this time
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No modifications at this time
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M. Ophthalmic
No modifications at this time
N. Orthopedic
11–223 .............. 11–311 ISO 14243–2 Third edition 2016–09–01 Implants for surgery—Wear of Withdrawn and replaced with
total knee-joint prostheses—Part 2: Methods of measurement. newer version.
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![Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices 94391
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
11–225 .............. 11–312 ISO 7206–4 Third edition 2010–06–15 Implants for surgery—Compo- Withdrawn and replaced with
nents for partial and total knee joint prostheses—Part 2: Articulating newer version including amend-
surfaces made of metal, ceramic and plastics materials [Including ment.
AMENDMENT 1 (2016)].
11–231 .............. 11–313 ISO 7207–2 Second edition 2011–07–01 Implants for surgery—Com- Withdrawn and replaced with
ponents for partial and total knee joint prostheses—Part 2: Articu- newer version including amend-
lating surfaces made of metal, ceramic and plastics materials [In- ment.
cluding AMENDMENT 1 (2016)].
11–249 .............. 11–314 ISO 14242–2 Second edition 2016–09–15 Implants for surgery—Wear Withdrawn and replaced with
of total hip-joint prostheses—Part 2: Methods of measurement. newer version.
11–268 .............. 11–315 ASTM F1829–16 Standard Test Method for Static Evaluation of Ana- Withdrawn and replaced with
tomic Glenoid Locking Mechanism in Shear. newer version.
11–287 .............. ........................ ASTM F382–14 Standard Specification and Test Method for Metallic Withdrawn. See 11–297.
Bone Plates.
11–298 .............. 11–316 ASTM F1264–16 Standard Specification and Test Methods for Withdrawn and replaced with
Intramedullary Fixation Devices. newer version.
O. Physical Medicine
No modifications at this time
P. Radiology
12–49 ................ 12–303 IEC 61303 Edition 1.0 1994–09 Medical electrical equipment—Radio- Withdrawn and replaced with new
nuclide calibrators—Particular methods for describing performance version including corrigendum.
[Including CORRIGENDUM 1 (2016)].
12–235 .............. 12–304 IEC 60731 Edition 3.1 2016–04 Consolidated Version Medical elec- Withdrawn and replaced with
trical equipment—Dosimeters with ionization chambers as used in newer version.
radiotherapy.
12–263 .............. 12–305 ISO 13694 Second edition 2015–11–15 Optics and Photonics—Lasers Withdrawn and replaced with
and laser-related equipment—Test methods for laser beam power newer version.
(energy) density distribution.
Q. Software/Informatics
13–27 ................ 13–85 CLSI AUTO11–A2 October 2014 Information Technology Security of In Withdrawn and replaced with
Vitro Diagnostic Instruments and Software Systems; Approved newer version.
Standard—Second Edition.
R. Sterility
14–169 .............. ........................ ASTM F2391–05 (Reapproved 2016) Standard Test Method for Meas- Reaffirmation.
uring Package and Seal Integrity Using Helium as the Tracer Gas.
14–197 .............. 14–496 ASTM F1608–16 Standard Test Method for Microbial Ranking of Po- Withdrawn and replaced with
rous Packaging Materials (Exposure Chamber Method). newer version.
14–229 .............. 14–497 ASTM F1980–16 Standard Guide for Accelerated Aging of Sterile Bar- Withdrawn and replaced with
rier Systems for Medical Devices. newer version.
14–285 .............. ........................ ANSI/AAMI/ISO 14161–2009/(R)2014 Sterilization of health care prod- Reaffirmation.
ucts—Biological indicators—Guidance for the selection, use and in-
terpretation of results.
14–311 .............. ........................ ANSI/AAMI ST55:2010/(R)2014 Table-top steam sterilizers .................. Reaffirmation.
14–339 .............. ........................ ANSI/AAMI/ISO 20857:2010/(R)2015 (Revision of ANSI/AAMI/ Reaffirmation.
ST63:2002) Sterilization of health care products—Dry heat—Re-
quirements for the development, validation and routine control of a
sterilization process for medical devices.
14–349 .............. ........................ ANSI/AAMI/ISO 13408–3:2006/(R)2015 Aseptic processing of health Reaffirmation.
care products—Part 3: Lyophilization.
14–360 .............. ........................ ANSI/AAMI ST72:2011/(R)2016 Bacterial endotoxins—Test methods, Reaffirmation.
routine monitoring, and alternatives to batch testing.
14–453 .............. 14–498 ASTM F2097–16 Standard Guide for Design and Evaluation of Pri- Withdrawn and replaced with
mary Flexible Packaging for Medical Products. newer version.
14–462 .............. 14–499 ASTM D4169–16 Standard Practice for Performance Testing of Ship- Withdrawn and replaced with
mstockstill on DSK3G9T082PROD with NOTICES
ping Containers and Systems. newer version.
14–479 .............. 14–500 ISO 14644–1 Second edition 2015–12–15 Cleanrooms and associated Withdrawn and replaced with new
controlled environments—Part 1: Classification of air cleanliness by recognition number.
particle concentration.
14–489 .............. ........................ USP 39–NF34:2016 Biological Indicator for Steam Sterilization—Self Withdrawn.
Contained.
14–490 .............. ........................ USP 39–NF34:2016 Biological Indicator for Dry-Heat Sterilization, Withdrawn.
Paper Carrier.
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![94392 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
14–491 .............. ........................ USP 39–NF34:2016 Biological Indicator for Ethylene Oxide Steriliza- Withdrawn.
tion, Paper Carrier.
14–492 .............. ........................ USP 39–NF34:2016 Biological Indicator for Steam Sterilization, Paper Withdrawn.
Carrier.
S. Tissue Engineering
15–34 ................ 15–48 ASTM F2605–16 Standard Test Method for Determining the Molar Withdrawn and replaced with
Mass of Sodium Alginate by Size Exclusion Chromatography with newer version.
Multi-angle Light Scattering Detection (SEC–MALS).
1 All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries added as modifications to the list of
In table 2, FDA provides the listing of recognized standards under Recognition
new entries and consensus standards List Number: 046.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and date
A. Anesthesiology
1–119 ................. Tracheal tubes designed for laser surgery—Requirements for marking and ac- ISO 14408 Third edition 2016–02–15.
companying information.
1–120 ................. Anaesthetic and respiratory equipment—General requirements for airways and re- ISO 18190 First edition 2016–11–01.
lated equipment.
B. Biocompatibility
2–245 ................. Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity ...... ISO 10993–5 Third edition 2009–06–01.
C. Cardiovascular
3–145 ................. Cardiovascular implants—Cardiac valve prostheses—Part 1: General require- ISO 5840–1:2015 First edition 2015–09–
ments. 15.
3–146 ................. Cardiovascular implants—Cardiac valve prostheses—Part 1: General require- ANSI/AAMI/ISO 5840–1: 2015.
ments.
3–147 ................. Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted ISO 5840–2: 2015 First edition 2015–
heart valve substitutes. 09–15.
3–148 ................. Cardiovascular implants—Cardiac valve prostheses — Part 2: Surgically im- ANSI/AAMI/ISO 5840–2: 2015.
planted heart valve substitutes.
D. Dental/Ear, Nose, and Throat (ENT)
4–229 ................. Medical electrical equipment—Part 2–60: Particular requirements for the basic IEC 80601–2–60 Edition 1.0 2012–02.
safety and essential performance of dental equipment.
E. General I (Quality Systems/Risk Management) (QS/RM)
5–115 ................. Small-bore connectors for liquids and gases in healthcare applications—Part 7: ISO 80369–7 First edition 2016–10–15.
Connectors for intravascular or hypodermic applications.
5–116 ................. Graphical symbols—Safety colours and safety signs—Registered safety signs [In- ISO 7010 Second edition 2011–06–01.
cluding AMENDMENT 1 (2012) through AMENDMENT 7 (2016)].
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–19 ................. Medical electrical equipment—Part 4–2: Guidance and interpretation—Electro- IEC TR 60601–4–2 Edition 1.0 2016–05.
magnetic immunity: Performance of medical electrical equipment and medical
electrical systems.
19–20 ................. American National Standard Guide for Electrostatic Discharge Test Methodolo- ANSI C63.16–2016 (Revision of ANSI
mstockstill on DSK3G9T082PROD with NOTICES
gies and Acceptance Criteria for Electronic Equipment. C63.16–1993).
19–21 ................. Medical Electrical Equipment and System Electromagnetic Immunity Test for Ex- AIM Standard Rev. 1.00 2016–08–22.
posure to Radio Frequency Identification Readers—An AIM Standard.
G. General Hospital/General Plastic Surgery (GH/GPS)
No new entries at this time.
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![94394 Federal Register / Vol. 81, No. 247 / Friday, December 23, 2016 / Notices
IV. List of Recognized Standards announcing ‘‘Modification to the List of Electronic Submissions
FDA maintains the Agency’s current Recognized Standards, Recognition List Submit electronic comments in the
list of FDA Recognized Consensus Number: 046’’ will be available at http:// following way:
Standards in a searchable database that www.fda.gov/MedicalDevices/ • Federal eRulemaking Portal:
may be accessed directly at FDA’s DeviceRegulationandGuidance/ https://www.regulations.gov. Follow the
Internet site at http:// Standards/ucm123792.htm. You may instructions for submitting comments.
www.accessdata.fda.gov/scripts/cdrh/ access ‘‘Guidance on the Recognition Comments submitted electronically,
cfdocs/cfStandards/search.cfm. FDA and Use of Consensus Standards,’’ and including attachments, to https://
will incorporate the modifications and the searchable database for ‘‘FDA www.regulations.gov will be posted to
revisions described in this notice into Recognized Consensus Standards’’ at the docket unchanged. Because your
the database and, upon publication in http://www.fda.gov/MedicalDevices/ comment will be made public, you are
the Federal Register, this recognition of DeviceRegulationandGuidance/ solely responsible for ensuring that your
consensus standards will be effective. Standards. comment does not include any
FDA will announce additional Dated: December 19, 2016. confidential information that you or a
modifications and revisions to the list of Leslie Kux, third party may not wish to be posted,
recognized consensus standards, as Associate Commissioner for Policy. such as medical information, your or
needed, in the Federal Register once a [FR Doc. 2016–31008 Filed 12–22–16; 8:45 am] anyone else’s Social Security number, or
year, or more often if necessary. BILLING CODE 4164–01–P
confidential business information, such
Beginning with Recognition List 033, as a manufacturing process. Please note
FDA no longer announces minor that if you include your name, contact
revisions to the list of recognized DEPARTMENT OF HEALTH AND information, or other information that
consensus standards such as technical HUMAN SERVICES identifies you in the body of your
contact person, devices affected, comments, that information will be
processes affected, Code of Federal Food and Drug Administration posted on https://www.regulations.gov.
Regulations citations, and product • If you want to submit a comment
codes. [Docket No. FDA–2007–D–0369] with confidential information that you
do not wish to be made available to the
V. Recommendation of Standards for Product-Specific Bioequivalence public, submit the comment as a
Recognition by FDA Recommendations; Draft and Revised written/paper submission and in the
Any person may recommend Draft Guidances for Industry; manner detailed (see ‘‘Written/Paper
consensus standards as candidates for Availability Submissions’’ and ‘‘Instructions’’).
recognition under section 514 of the AGENCY: Food and Drug Administration, Written/Paper Submissions
FD&C Act by submitting such HHS.
recommendations, with reasons for the Submit written/paper submissions as
recommendation, to standards@ ACTION: Notice of availability. follows:
cdrh.fda.gov. To be properly considered, SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
such recommendations should contain, Administration (FDA or Agency) is written/paper submissions): Division of
at a minimum, the following announcing the availability of Dockets Management (HFA–305), Food
information: (1) Title of the standard, (2) additional draft and revised draft and Drug Administration, 5630 Fishers
any reference number and date, (3) product-specific bioequivalence (BE) Lane, Rm. 1061, Rockville, MD 20852.
name and address of the national or recommendations. The • For written/paper comments
international standards development recommendations provide product- submitted to the Division of Dockets
organization, (4) a proposed list of specific guidance on the design of BE Management, FDA will post your
devices for which a declaration of studies to support abbreviated new drug comment, as well as any attachments,
conformity to this standard should applications (ANDAs). In the Federal except for information submitted,
routinely apply, and (5) a brief Register of June 11, 2010, FDA marked and identified, as confidential,
identification of the testing or announced the availability of a guidance if submitted as detailed in
performance or other characteristics of for industry entitled ‘‘Bioequivalence ‘‘Instructions.’’
the device(s) that would be addressed Recommendations for Specific Instructions: All submissions received
by a declaration of conformity. Products’’ that explained the process must include the Docket No. FDA–
that would be used to make product- 2007–D–0369 for ‘‘Product-Specific
VI. Electronic Access Bioequivalence Recommendations; Draft
specific BE recommendations available
You may obtain a copy of ‘‘Guidance to the public on FDA’s Web site. The BE and Revised Draft Guidances for
on the Recognition and Use of recommendations identified in this Industry.’’ Received comments will be
Consensus Standards’’ by using the notice were developed using the process placed in the docket and, except for
Internet. The Center for Devices and described in that guidance. those submitted as ‘‘Confidential
Radiological Health (CDRH) maintains a Submissions,’’ publicly viewable at
DATES: Although you can comment on
site on the Internet for easy access to https://www.regulations.gov or at the
information including text, graphics, any guidance at any time (see 21 CFR Division of Dockets Management
and files that you may download to a 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday
personal computer with access to the considers your comment on this draft through Friday.
mstockstill on DSK3G9T082PROD with NOTICES
Internet. Updated on a regular basis, the guidance before it begins work on the • Confidential Submissions—To
CDRH home page, http://www.fda.gov/ final version of the guidance, submit submit a comment with confidential
MedicalDevices, includes a link to either electronic or written comments information that you do not wish to be
standards-related documents including on the draft guidance by February 21, made publicly available, submit your
the guidance and the current list of 2017. comments only as a written/paper
recognized standards. After publication ADDRESSES: You may submit comments submission. You should submit two
in the Federal Register, this notice as follows: copies total. One copy will include the
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Document Created: 2016-12-23 12:29:12
Document Modified: 2016-12-23 12:29:12
| 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 December 23, 2016. | |
| 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 | 81 FR 94388 |
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