81 FR 48809 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 143 (July 26, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 143 (July 26, 2016)
| Page Range | 48809-48813 | |
| FR Document | 2016-17570 |
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)] [Notices] [Pages 48809-48813] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17570] [[Page 48809]] ----------------------------------------------------------------------- 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: 044 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: 044 (Recognition List Number: 044), 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 July 26, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 043. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 044 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: 044 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: 044'' to Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796- 6287, standards@cdrh.fda.gov. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled ``Recognition and Use of Consensus Standards.'' The [[Page 48810]] 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: 044 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: 044'' 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. Biocompatibility ---------------------------------------------------------------------------------------------------------------- 2-93.................................. .............. ASTM F763-04 (Reapproved 2010) Extent of recognition, Standard Practice for Short- Relevant guidance. Term Screening of Implant Materials. 2-94.................................. .............. ASTM F981-04 (Reapproved 2010) Extent of recognition, Standard Practice for Relevant guidance. Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone. 2-114................................. .............. ASTM F1877-05 (Reapproved Extent of recognition, 2010) Standard Practice for Relevant guidance. Characterization of Particles. 2-117................................. 2-226 ANSI/AAMI/ISO 10993-3:2014 Withdrawn and replaced Biological evaluation of with newer version. medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. 2-118................................. .............. ANSI/AAMI/ISO 10993-11:2006/ Reaffirmation, Extent of (R) 2014 Biological recognition, Relevant evaluation of medical guidance. devices--Part 11: Tests for systemic toxicity. 2-119................................. .............. ASTM F813-07 (Reapproved 2012) Extent of recognition, Standard Practice for Direct Relevant guidance. Contact Cell Culture Evaluation of Materials for Medical Devices. 2-120................................. .............. ANSI/AAMI/ISO 10993-6:2007/(R) Reaffirmation, Extent of 2014 Biological evaluation of recognition, Relevant medical devices--Part 6: guidance. Tests for local effects after implantation. 2-122................................. .............. ASTM F719-81 (Reapproved 2012) Extent of recognition, Standard Practice for Testing Relevant guidance. Biomaterials in Rabbits for Primary Skin Irritation. 2-124................................. .............. ASTM F750-87 (Reapproved 2012) Extent of recognition, Standard Practice for Relevant guidance. Evaluating Material Extracts By Systemic Injection in the Mouse. 2-126................................. .............. ASTM F748-06 (Reapproved 2010) Extent of recognition, Standard Practice for Relevant guidance. Selecting Generic Biological Test Methods for Materials and Devices. 2-133................................. .............. ASTM F1408-97 (Reapproved Extent of recognition, 2013) Standard Practice for Relevant guidance. Subcutaneous Screening Test for Implant Materials. 2-134................................. .............. ASTM F2065-00 (Reapproved Extent of recognition, 2010) Standard Practice for Relevant guidance. Testing for Alternative Pathway Complement Activation in Serum by Solid Materials. 2-136................................. .............. ASTM E1262-88 (Reapproved Extent of recognition, 2013) Standard Guide for Relevant guidance. Performance of Chinese Hamster Ovary Cell/ Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay. 2-141................................. .............. ASTM F1984-99 (Reapproved Extent of recognition, 2013) Standard Practice for Relevant guidance. Testing for Whole Complement Activation in Serum by Solid Materials. 2-142................................. 2-227 ASTM F1983-14 Standard Withdrawn and replaced Practice for Assessment of with newer version. Selected Tissue Effects of Absorbable Biomaterials for Implant Applications. 2-145................................. .............. ASTM F1439-03 (Reapproved Extent of recognition, 2013) Standard Guide for Relevant guidance. Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials. 2-153................................. .............. ANSI/AAMI/ISO 10993-5:2009/(R) Extent of recognition, 2014 Biological evaluation of Relevant guidance. medical devices--Part 5: Tests for in vitro cytotoxicity. 2-155................................. .............. ASTM F2147-01 (Reapproved Extent of recognition, 2010) Standard Practice for Relevant guidance. Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. 2-156................................. .............. ANSI/AAMI 10993-1:2009/(R) Extent of recognition, 2013 Biological evaluation of Relevant guidance. medical devices--Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]. 2-162................................. .............. ASTM F1903-10 Standard Extent of recognition, Practice for Testing For Relevant guidance. Biological Responses to Particles In Vitro. [[Page 48811]] 2-163................................. .............. ANSI/AAMI/ISO 10993-9: 2009/ Reaffirmation, Extent of (R) 2014 Biological recognition, Relevant evaluation of medical guidance. devices--Part 9: Framework for identification and quantification of potential degradation products. 2-165................................. .............. ANSI/AMMI/ISO 10993-14:2001/ Relevant guidance. (R) 2011, Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products form ceramics. 2-167................................. .............. ISO TS 10993-19 First edition Extent of recognition, 2006-06-01 Biological Relevant guidance. evaluation of medical devices--Part 19: Physio- chemical, morphological and topographical characterization of materials. 2-168................................. .............. ISO 10993-9 Second edition Extent of recognition, 2009-12-15 Biological Relevant guidance. evaluation of medical devices--Part 9: Framework for identification and quantification of potential degradation products. 2-169................................. .............. ISO 10993-13 Second edition Extent of recognition, 2010-06-15, Biological Relevant guidance. evaluation of medical devices--Part 13: Identification and quantification of degradation products from polymeric medical devices. 2-170................................. .............. ISO 10993-14 First edition Relevant guidance. 2001-11-15, Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics. 2-171................................. .............. ISO 10993-16 Second edition Relevant guidance. 2010-02-15, Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables. 2-172................................. .............. ANSI/AAMI/ISO TIR 10993- Extent of recognition, 19:2006 Biological evaluation Relevant guidance. of medical devices--Part 19: Physicochemical, morphological, and topographical characterization of materials. 2-173................................. .............. ANSI/AAMI/ISO 10993-10:2010/ Reaffirmation, Extent of (R) 2014 Biological recognition, Relevant evaluation of medical guidance. devices--Part 10: Tests for irritation and skin sensitization. 2-174................................. .............. ISO 10993-10 Third Edition Extent of recognition, 2010-08-01 Biological Relevant guidance. evaluation of medical devices--Part 10: Tests for irritation and skin sensitization. 2-175................................. 2-228 ISO 10993-3:2014 Third edition Withdrawn and replaced 2014-10-1 Biological with newer version. evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. 2-176................................. .............. ISO 10993-11 Second edition Extent of recognition, 2006-08-15 Biological Relevant guidance. evaluation of medical devices--Part 11: Tests for systemic toxicity. 2-177................................. .............. ISO 10993-06 Second edition Extent of recognition, 2007-04-15 Biological Relevant guidance. evaluation of medical devices--Part 6: Tests for local effects after implantation. 2-180................................. .............. ANSI/AAMI/ISO 10993-16:2010/ Relevant guidance. (R) 2014, Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables from medical devices. 2-189................................. .............. ASTM F895-11 Standard Test Extent of recognition, Method for Agar Diffusion Relevant guidance. Cell Culture Screening for Cytotoxicity. 2-190................................. .............. ANSI/AAMI/ISO 10993-13:2010/ Reaffirmation, Extent of (R) 2014 Biological recognition, Relevant evaluation of medical guidance. devices--Part 13: Identification and quantification of degradation products from polymeric medical devices. 2-191................................. .............. ISO 10993-12 Fourth edition Extent of recognition, 2012-07-01 Biological Relevant guidance. evaluation of medical devices--Part 12: Sample preparation and reference materials. 2-197................................. .............. ASTM F749-13 Standard Practice Extent of recognition, for Evaluating Material Relevant guidance. Extracts by Intracutaneous Injection in the Rabbit. 2-198................................. .............. ANSI/AAMI/ISO 10993-12:2012 Extent of recognition, Biological evaluation of Relevant guidance. medical devices--Part 12: Sample preparation and reference materials. 2-204................................. .............. ASTM F720-13 Standard Practice Extent of recognition, for Testing Guinea Pigs for Relevant guidance. Contact Allergens: Guinea Pig Maximization Test. 2-206................................. .............. ASTM F2148-13 Standard Extent of recognition, Practice for Evaluation of Relevant guidance. Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). 2-207................................. .............. ASTM F756-13 Standard Practice Extent of recognition, for Assessment of Hemolytic Relevant guidance. Properties of Materials. 2-213................................. .............. ASTM F1904-14 Standard Extent of recognition, Practice for Testing the Relevant guidance. Biological Responses to Particles In Vivo. 2-214................................. .............. ASTM F619-14 Standard Practice Extent of recognition, for Extraction of Medical Relevant guidance. Plastics. 2-215................................. 2-229 USP 39-NF34:2016 <87> Withdrawn and replaced Biological Reactivity test, with a newer version. In Vitro--Direct Contact Test. 2-216................................. 2-230 USP 39-NF34:2016 <87> Withdrawn and replaced Biological Reactivity Test, with a newer version. In Vitro--Elution Test. 2-217................................. 2-231 USP 39-NF34: 2016 <88> Change in title, Biological Reactivity Tests, Withdrawn and replaced In Vivo. with a newer version. 2-218................................. .............. USP 39-NF34: 2016 <88> Withdrawn; See 2-231. Biological Reactivity Tests In Vivo, Classification of Plastics--Intracutaneous Test. 2-219................................. .............. USP 39-NF34: 2016 <88> Withdrawn; See 2-231. Biological Reactivity Tests In Vivo, Classification of Plastics--Systemic Injection Test. [[Page 48812]] 2-220................................. .............. ISO 10993-1 Fourth edition Extent of recognition, 2009-10-15 Biological Relevant guidance. evaluation of medical devices--Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]. 2-221................................. .............. ANSI/AAMI/ISO 10993-2:2006/(R) Extent of recognition, 2014 Biological evaluation of Relevant guidance. medical devices--Part 2: Animal welfare requirements. 2-222................................. .............. ISO 10993-2 Second edition Extent of recognition, 2006-07-15 Biological Relevant guidance. evaluation of medical devices--Part 2: Animal welfare requirements. 2-223................................. .............. ASTM F2901-13, Standard guide Relevant guidance. for selecting tests to evaluate potential neurotoxicity of medical devices. 2-225................................. .............. ASTM F2567-06 (Reapproved Relevant guidance. 2010), Standard practice for testing for classical complement activation in serum by solid materials. ---------------------------------------------------------------------------------------------------------------- B. Sterility ---------------------------------------------------------------------------------------------------------------- 14-477................................ 2-232 USP 39-NF34:2016 <151> Pyrogen Transferred to Test. Biocompatibility; Relevant guidance. ---------------------------------------------------------------------------------------------------------------- \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: 044. Table 2--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and Date ------------------------------------------------------------------------ A. Biocompatibility ------------------------------------------------------------------------ 2-233......................... Standard Test Method F2382-04 for Assessment of (Reapproved Intravascular Medical 2010). Device Materials on Partial Thromboplastin Time (PTT). 2-234......................... Biological Evaluation ANSI/AAMI/ISO of Medical Devices-- 10993-4:2002/ Part 4: Selection of (R)2013 & tests for interaction A1:2006/ with blood [Including (R)2013. Amendment 1(2006)]. 2-235......................... Biological Evaluation ISO 10994-4 of Medical Devices-- Second edition Part 4: Selection of 2002-10-15 tests for interaction Amendment 1 with blood [Including 2006-07-15. Amendment 1(2006)]. 2-236......................... Biological evaluation ANSI/AAMI/ISO of medical devices-- 10993-17:2002/ Part 17: (R)2012. Establishment of allowable limits for leachable substances. 2-237......................... Biological evaluation ISO 10993-17 of medical devices-- First edition Part 17: 2002-12-01. Establishment of allowable limits for leachable substances. 2-238......................... Biological evaluation ANSI/AAMI BE 83: of medical devices-- 2006/(R)2011. Part 18: Chemical characterization of materials. 2-239......................... Biological evaluation ANSI/AAMI/ISO of medical devices-- TIR 10993- Part 20: Principles 20:2006. and methods for immunotoxicology testing of medical devices. 2-240......................... Biological evaluation ISO/TS 10993-20 of medical devices-- First edition Part 20: Principles 2006-08-01. and methods for immunotoxicology testing of medical devices. 2-241......................... Cardiovascular ISO/TR 37137 biological evaluation First edition of medical devices-- 2014-05-15. Guidance for absorbable implants. 2-242......................... Cardiovascular ANSI/AAMI/ISO TR biological evaluation 37137: 2014. of medical devices-- Guidance for absorbable implants. 2-243......................... Biological evaluation ISO/TR 10993- of medical devices-- 33:2015 First Part 33: Guidance on edition 2015-03- tests to evaluate 01. genotoxicity. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards FDA maintains the Agency's current list of FDA Recognized Consensus Standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with Recognition List 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to standards@cdrh.fda.gov. To be properly considered, [[Page 48813]] 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: 044'' 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: July 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17570 Filed 7-25-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 48809
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
56469, September 18, 2015, or access
Food and Drug Administration Written/Paper Submissions
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 http://
Lane, Rm. 1061, Rockville, MD 20852. www.regulations.gov and insert the
044 • For written/paper comments docket number, found in brackets in the
AGENCY: Food and Drug Administration, submitted to the Division of Dockets heading of this document, into the
HHS. Management, FDA will post your ‘‘Search’’ box and follow the prompts
comment, as well as any attachments, and/or go to the Division of Dockets
ACTION: Notice. except for information submitted, Management, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug marked and identified, as confidential, 1061, Rockville, MD 20852.
Administration (FDA or Agency) is if submitted as detailed in An electronic copy of Recognition List
announcing a publication containing ‘‘Instructions.’’ Number: 044 is available on the Internet
Instructions: All submissions received
modifications the Agency is making to at http://www.fda.gov/MedicalDevices/
must include the Docket No. FDA–
the list of standards FDA recognizes for DeviceRegulationandGuidance/
2004–N–0451 for ‘‘Food and Drug
use in premarket reviews (FDA Standards/ucm123792.htm. See section
Administration Modernization Act of
Recognized Consensus Standards). This VI of this document for electronic access
1997: Modifications to the List of
publication, entitled Modifications to to the searchable database for the
Recognized Standards, Recognition List
the List of Recognized Standards, current list of FDA recognized
Number: 044.’’ Received comments will
Recognition List Number: 044 consensus standards, including
be placed in the docket and, except for
(Recognition List Number: 044), will Recognition List Number: 044
those submitted as ‘‘Confidential
assist manufacturers who elect to Submissions,’’ publicly viewable at modifications and other standards
declare conformity with consensus http://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: 044’’ to Scott
any time. These modifications to the list whether to amend the current listing of A. Colburn, Center for Devices and
of recognized standards are effective modifications to the list of recognized Radiological Health, Food and Drug
July 26, 2016. standards, Recognition List Number: Administration, 10903 New Hampshire
ADDRESSES: You may submit comments 043. Ave., Bldg. 66, Rm. 5514, Silver Spring,
as follows: • Confidential Submissions—To MD 20993. Send one self-addressed
submit a comment with confidential adhesive label to assist that office in
Electronic Submissions information that you do not wish to be processing your request, or fax your
Submit electronic comments in the made publicly available, submit your request to 301–847–8149.
following way: comments only as a written/paper FOR FURTHER INFORMATION CONTACT:
• Federal eRulemaking Portal: http:// submission. You should submit two Scott A. 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 http:// ‘‘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)
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
srobinson on DSK5SPTVN1PROD with NOTICES
comments, that information will be sheet and not in the body of your premarket review submissions or other
posted on http://www.regulations.gov. comments and you must identify this requirements.
• If you want to submit a comment information as ‘‘confidential.’’ Any In a notice published in the Federal
with confidential information that you information marked as ‘‘confidential’’ Register of February 25, 1998 (63 FR
do not wish to be made available to the will not be disclosed except in 9561), FDA announced the availability
public, submit the comment as a accordance with 21 CFR 10.20 and other of a guidance entitled ‘‘Recognition and
written/paper submission and in the applicable disclosure law. For more Use of Consensus Standards.’’ The
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![48810 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
notice described how FDA would See section VI of this document for use the term ‘‘Recognition List Number:
implement its standard recognition electronic access information. Interested 044’’ to identify these current
program and provided the initial list of persons should review the modifications.
recognized standards. supplementary information sheet for the In table 1, FDA describes the
Modifications to the initial list of standard to understand fully the extent following modifications: (1) The
recognized standards, as published in to which FDA recognizes the standard. withdrawal of standards and their
the Federal Register, can be accessed at
II. Modifications to the List of replacement by others, if applicable; (2)
http://www.fda.gov/MedicalDevices/
Recognized Standards, Recognition List the correction of errors made by FDA in
DeviceRegulationandGuidance/
Number: 044 listing previously recognized standards;
Standards/ucm123792.htm.
These notices describe the addition, FDA is announcing the addition, and (3) the changes to the
withdrawal, and revision of certain withdrawal, correction, and revision of supplementary information sheets of
standards recognized by FDA. The certain consensus standards the Agency recognized standards that describe
Agency maintains hypertext markup will recognize for use in premarket revisions to the applicability of the
language (HTML) and portable submissions and other requirements for standards.
document format (PDF) versions of the devices. FDA will incorporate these In section III, FDA lists modifications
list of FDA Recognized Consensus modifications in the list of FDA the Agency is making that involve the
Standards. Both versions are publicly Recognized Consensus Standards in the initial addition of standards not
accessible at the Agency’s Internet site. Agency’s searchable database. FDA will previously recognized by FDA.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
A. Biocompatibility
2–93 ................... ........................ ASTM F763–04 (Reapproved 2010) Standard Practice for Short-Term Extent of recognition, Relevant
Screening of Implant Materials. guidance.
2–94 ................... ........................ ASTM F981–04 (Reapproved 2010) Standard Practice for Assess- Extent of recognition, Relevant
ment of Compatibility of Biomaterials for Surgical Implants with Re- guidance.
spect to Effect of Materials on Muscle and Bone.
2–114 ................. ........................ ASTM F1877–05 (Reapproved 2010) Standard Practice for Character- Extent of recognition, Relevant
ization of Particles. guidance.
2–117 ................. 2–226 ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical de- Withdrawn and replaced with
vices—Part 3: Tests for genotoxicity, carcinogenicity, and reproduc- newer version.
tive toxicity.
2–118 ................. ........................ ANSI/AAMI/ISO 10993–11:2006/(R) 2014 Biological evaluation of Reaffirmation, Extent of recogni-
medical devices—Part 11: Tests for systemic toxicity. tion, Relevant guidance.
2–119 ................. ........................ ASTM F813–07 (Reapproved 2012) Standard Practice for Direct Con- Extent of recognition, Relevant
tact Cell Culture Evaluation of Materials for Medical Devices. guidance.
2–120 ................. ........................ ANSI/AAMI/ISO 10993–6:2007/(R) 2014 Biological evaluation of med- Reaffirmation, Extent of recogni-
ical devices—Part 6: Tests for local effects after implantation. tion, Relevant guidance.
2–122 ................. ........................ ASTM F719–81 (Reapproved 2012) Standard Practice for Testing Extent of recognition, Relevant
Biomaterials in Rabbits for Primary Skin Irritation. guidance.
2–124 ................. ........................ ASTM F750–87 (Reapproved 2012) Standard Practice for Evaluating Extent of recognition, Relevant
Material Extracts By Systemic Injection in the Mouse. guidance.
2–126 ................. ........................ ASTM F748–06 (Reapproved 2010) Standard Practice for Selecting Extent of recognition, Relevant
Generic Biological Test Methods for Materials and Devices. guidance.
2–133 ................. ........................ ASTM F1408–97 (Reapproved 2013) Standard Practice for Subcuta- Extent of recognition, Relevant
neous Screening Test for Implant Materials. guidance.
2–134 ................. ........................ ASTM F2065–00 (Reapproved 2010) Standard Practice for Testing for Extent of recognition, Relevant
Alternative Pathway Complement Activation in Serum by Solid Ma- guidance.
terials.
2–136 ................. ........................ ASTM E1262–88 (Reapproved 2013) Standard Guide for Perform- Extent of recognition, Relevant
ance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine guidance.
Phosphoribosyl Transferase Gene Mutation Assay.
2–141 ................. ........................ ASTM F1984–99 (Reapproved 2013) Standard Practice for Testing for Extent of recognition, Relevant
Whole Complement Activation in Serum by Solid Materials. guidance.
2–142 ................. 2–227 ASTM F1983–14 Standard Practice for Assessment of Selected Tis- Withdrawn and replaced with
sue Effects of Absorbable Biomaterials for Implant Applications. newer version.
2–145 ................. ........................ ASTM F1439–03 (Reapproved 2013) Standard Guide for Performance Extent of recognition, Relevant
of Lifetime Bioassay for the Tumorigenic Potential of Implant Mate- guidance.
rials.
2–153 ................. ........................ ANSI/AAMI/ISO 10993–5:2009/(R) 2014 Biological evaluation of med- Extent of recognition, Relevant
srobinson on DSK5SPTVN1PROD with NOTICES
ical devices—Part 5: Tests for in vitro cytotoxicity. guidance.
2–155 ................. ........................ ASTM F2147–01 (Reapproved 2010) Standard Practice for Guinea Extent of recognition, Relevant
Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. guidance.
2–156 ................. ........................ ANSI/AAMI 10993–1:2009/(R) 2013 Biological evaluation of medical Extent of recognition, Relevant
devices—Part 1: Evaluation and testing within a risk management guidance.
process [Including: Technical Corrigendum 1 (2010)].
2–162 ................. ........................ ASTM F1903–10 Standard Practice for Testing For Biological Re- Extent of recognition, Relevant
sponses to Particles In Vitro. guidance.
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![48812 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Replacement
Old recognition recognition Title of standard 1 Change
No. No.
2–220 ................. ........................ ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of Extent of recognition, Relevant
medical devices—Part 1: Evaluation and testing within a risk man- guidance.
agement process [Including: Technical Corrigendum 1 (2010)].
2–221 ................. ........................ ANSI/AAMI/ISO 10993–2:2006/(R) 2014 Biological evaluation of med- Extent of recognition, Relevant
ical devices—Part 2: Animal welfare requirements. guidance.
2–222 ................. ........................ ISO 10993–2 Second edition 2006–07–15 Biological evaluation of Extent of recognition, Relevant
medical devices—Part 2: Animal welfare requirements. guidance.
2–223 ................. ........................ ASTM F2901–13, Standard guide for selecting tests to evaluate po- Relevant guidance.
tential neurotoxicity of medical devices.
2–225 ................. ........................ ASTM F2567–06 (Reapproved 2010), Standard practice for testing for Relevant guidance.
classical complement activation in serum by solid materials.
B. Sterility
14–477 ............... 2–232 USP 39–NF34:2016 <151> Pyrogen Test ............................................. Transferred to Biocompatibility;
Relevant guidance.
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: 044.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and Date
A. Biocompatibility
2–233 ...................... Standard Test Method for Assessment of Intravascular Medical Device Mate- F2382–04 (Reapproved 2010).
rials on Partial Thromboplastin Time (PTT).
2–234 ...................... Biological Evaluation of Medical Devices—Part 4: Selection of tests for inter- ANSI/AAMI/ISO 10993–4:2002/(R)2013
action with blood [Including Amendment 1(2006)]. & A1:2006/(R)2013.
2–235 ...................... Biological Evaluation of Medical Devices—Part 4: Selection of tests for inter- ISO 10994–4 Second edition 2002–10–
action with blood [Including Amendment 1(2006)]. 15 Amendment 1 2006–07–15.
2–236 ...................... Biological evaluation of medical devices—Part 17: Establishment of allowable ANSI/AAMI/ISO 10993–17:2002/
limits for leachable substances. (R)2012.
2–237 ...................... Biological evaluation of medical devices—Part 17: Establishment of allowable ISO 10993–17 First edition 2002–12–
limits for leachable substances. 01.
2–238 ...................... Biological evaluation of medical devices—Part 18: Chemical characterization of ANSI/AAMI BE 83: 2006/(R)2011.
materials.
2–239 ...................... Biological evaluation of medical devices—Part 20: Principles and methods for ANSI/AAMI/ISO TIR 10993–20:2006.
immunotoxicology testing of medical devices.
2–240 ...................... Biological evaluation of medical devices—Part 20: Principles and methods for ISO/TS 10993–20 First edition 2006–
immunotoxicology testing of medical devices. 08–01.
2–241 ...................... Cardiovascular biological evaluation of medical devices—Guidance for absorb- ISO/TR 37137 First edition 2014–05–
able implants. 15.
2–242 ...................... Cardiovascular biological evaluation of medical devices—Guidance for absorb- ANSI/AAMI/ISO TR 37137: 2014.
able implants.
2–243 ...................... Biological evaluation of medical devices—Part 33: Guidance on tests to evalu- ISO/TR 10993–33:2015 First edition
ate genotoxicity. 2015–03–01.
1 All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards consensus standards will be effective. Regulations citations, and product
FDA will announce additional codes.
FDA maintains the Agency’s current
modifications and revisions to the list of
list of FDA Recognized Consensus V. Recommendation of Standards for
Standards in a searchable database that recognized consensus standards, as
Recognition by FDA
may be accessed directly at FDA’s needed, in the Federal Register once a
srobinson on DSK5SPTVN1PROD with NOTICES
Internet site at http:// year, or more often if necessary. Any person may recommend
www.accessdata.fda.gov/scripts/cdrh/ Beginning with Recognition List 033, consensus standards as candidates for
cfdocs/cfStandards/search.cfm. FDA FDA no longer announces minor recognition under section 514 of the
will incorporate the modifications and revisions to the list of recognized FD&C Act by submitting such
revisions described in this notice into consensus standards such as technical recommendations, with reasons for the
the database and, upon publication in contact person, devices affected, recommendation, to standards@
the Federal Register, this recognition of processes affected, Code of Federal cdrh.fda.gov. To be properly considered,
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![Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 48813
such recommendations should contain, DEPARTMENT OF HEALTH AND 2009, amending the Federal Food, Drug,
at a minimum, the following HUMAN SERVICES and Cosmetic Act and providing FDA
information: (1) Title of the standard, (2) with the authority to regulate tobacco
any reference number and date, (3) Food and Drug Administration products (Pub. L. 111–31; 123 Stat.
name and address of the national or [Docket No. FDA–2013–N–0190] 1776). Section 3 of the Comprehensive
international standards development Smokeless Tobacco Health Education
organization, (4) a proposed list of Agency Information Collection Act of 1986 (the Smokeless Tobacco
devices for which a declaration of Activities; Submission for Office of Act) (15 U.S.C. 4402), as amended by
conformity to this standard should Management and Budget Review; section 204 of the Tobacco Control Act,
routinely apply, and (5) a brief Comment Request; Requirements requires, among other things, that all
identification of the testing or Under the Comprehensive Smokeless smokeless tobacco product packages
performance or other characteristics of Tobacco Health Education Act of 1986, and advertisements bear one of four
as Amended by the Family Smoking required warning statements. Section
the device(s) that would be addressed
Prevention and Tobacco Control Act 3(b)(3)(A) of the Smokeless Tobacco Act
by a declaration of conformity.
requires that the warnings be displayed
VI. Electronic Access AGENCY: Food and Drug Administration, on packaging and advertising for each
HHS. brand of smokeless tobacco ‘‘in
You may obtain a copy of ‘‘Guidance ACTION: Notice. accordance with a plan submitted by the
on the Recognition and Use of tobacco product manufacturer, importer,
Consensus Standards’’ by using the SUMMARY: The Food and Drug
distributor, or retailer’’ to, and approved
Administration (FDA) is announcing
Internet. The Center for Devices and by, FDA.
that a proposed collection of
Radiological Health (CDRH) maintains a This information collection-the
information has been submitted to the
site on the Internet for easy access to submission to FDA of warning plans for
Office of Management and Budget
information including text, graphics, smokeless tobacco products is
(OMB) for review and clearance under
and files that you may download to a statutorily mandated. The warning
the Paperwork Reduction Act of 1995.
personal computer with access to the plans will be reviewed by FDA, as
DATES: Fax written comments on the
Internet. Updated on a regular basis, the required by the Smokeless Tobacco Act,
collection of information by August 25, to determine whether the companies’
CDRH home page, http://www.fda.gov/ 2016.
MedicalDevices, includes a link to plans for the equal distribution and
ADDRESSES: To ensure that comments on display of warning statements on
standards-related documents including the information collection are received,
the guidance and the current list of packaging and the quarterly rotation of
OMB recommends that written warning statements in advertising for
recognized standards. After publication comments be faxed to the Office of
in the Federal Register, this notice each brand of smokeless tobacco
Information and Regulatory Affairs, products comply with section 3 of the
announcing ‘‘Modification to the List of OMB, Attn: FDA Desk Officer, FAX: Smokeless Tobacco Act, as amended.
Recognized Standards, Recognition List 202–395–7285, or emailed to oira_ Based on the Federal Trade
Number: 044’’ will be available at http:// submission@omb.eop.gov. All Commission’s (FTC’s) previous
www.fda.gov/MedicalDevices/ comments should be identified with the experience with the submission of
DeviceRegulationandGuidance/ OMB control number 0910–0671. Also warning plans and FDA’s experience,
Standards/ucm123792.htm. You may include the FDA docket number found FDA estimates that there are 52
access ‘‘Guidance on the Recognition in brackets in the heading of this companies affected by this information
and Use of Consensus Standards,’’ and document. collection. To account for the entry of
the searchable database for ‘‘FDA FOR FURTHER INFORMATION CONTACT: FDA new smokeless tobacco companies that
Recognized Consensus Standards’’ at PRA Staff, Office of Operations, Food may be affected by this information
http://www.fda.gov/MedicalDevices/ and Drug Administration, Three White collection, FDA is conservatively
DeviceRegulationandGuidance/ Flint North, 10A63, 11601 Landsdown estimating the total number of annual
Standards. St., North Bethesda, MD 20852, respondents to this collection of
Dated: July 19, 2016. PRAStaff@fda.hhs.gov. information to be 100.
Leslie Kux, SUPPLEMENTARY INFORMATION: In When the FTC requested an extension
compliance with 44 U.S.C. 3507, FDA of their approved warning plan
Associate Commissioner for Policy. information collection in 2007, based on
has submitted the following proposed
[FR Doc. 2016–17570 Filed 7–25–16; 8:45 am] over 20 years implementing the warning
collection of information to OMB for
BILLING CODE 4164–01–P review and clearance. plan requirements and taking into
account increased computerization and
Requirements Under the improvements in electronic
Comprehensive Smokeless Tobacco communication, the FTC estimated
Health Education Act of 1986, as submitting an initial plan would take 60
Amended by the Family Smoking hours. Based on FDA’s experience over
Prevention and Tobacco Control Act the past several years, FDA believes the
(OMB Control Number 0910–0671)— estimate of 60 hours to complete an
Extension initial rotational plan continues to be
srobinson on DSK5SPTVN1PROD with NOTICES
The Family Smoking Prevention and reasonable.
Tobacco Control Act (the Tobacco FDA estimates the burden of this
Control Act) was enacted on June 22, collection of information as follows:
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Document Created: 2018-02-08 08:00:39
Document Modified: 2018-02-08 08:00:39
| 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 July 26, 2016. | |
| Contact | Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796- 6287, [email protected] | |
| FR Citation | 81 FR 48809 |
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