| 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
| 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 |