Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044, 48809-48813 [2016-17570]

Download as PDF Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). 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. 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: SUMMARY: srobinson on DSK5SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 48809 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 E:\FR\FM\26JYN1.SGM 26JYN1 48810 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 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 Old recognition No. Replacement recognition No. Title of standard 1 Change A. Biocompatibility ........................ 2–94 ................... ........................ 2–114 ................. ........................ 2–117 ................. 2–226 2–118 ................. ........................ 2–119 ................. ........................ 2–120 ................. ........................ 2–122 ................. ........................ 2–124 ................. ........................ 2–126 ................. ........................ 2–133 ................. ........................ 2–134 ................. ........................ 2–136 ................. ........................ 2–141 ................. ........................ 2–142 ................. 2–227 2–145 ................. srobinson on DSK5SPTVN1PROD with NOTICES 2–93 ................... ........................ 2–153 ................. ........................ 2–155 ................. ........................ 2–156 ................. ........................ 2–162 ................. ........................ VerDate Sep<11>2014 20:28 Jul 25, 2016 ASTM F763–04 (Reapproved 2010) Standard Practice for Short-Term Screening of Implant Materials. ASTM F981–04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone. ASTM F1877–05 (Reapproved 2010) Standard Practice for Characterization of Particles. ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. ANSI/AAMI/ISO 10993–11:2006/(R) 2014 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity. ASTM F813–07 (Reapproved 2012) Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices. ANSI/AAMI/ISO 10993–6:2007/(R) 2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation. ASTM F719–81 (Reapproved 2012) Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation. ASTM F750–87 (Reapproved 2012) Standard Practice for Evaluating Material Extracts By Systemic Injection in the Mouse. ASTM F748–06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices. ASTM F1408–97 (Reapproved 2013) Standard Practice for Subcutaneous Screening Test for Implant Materials. ASTM F2065–00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials. ASTM E1262–88 (Reapproved 2013) Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay. ASTM F1984–99 (Reapproved 2013) Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials. ASTM F1983–14 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications. ASTM F1439–03 (Reapproved 2013) Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials. ANSI/AAMI/ISO 10993–5:2009/(R) 2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity. ASTM F2147–01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens. ANSI/AAMI 10993–1:2009/(R) 2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]. ASTM F1903–10 Standard Practice for Testing For Biological Responses to Particles In Vitro. Jkt 238001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM Extent of recognition, guidance. Extent of recognition, guidance. Relevant Relevant Extent of recognition, Relevant guidance. Withdrawn and replaced with newer version. Reaffirmation, Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Reaffirmation, Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, guidance. Relevant Extent of recognition, Relevant guidance. Withdrawn and replaced with newer version. Extent of recognition, Relevant guidance. Extent of recognition, guidance. Extent of recognition, guidance. Extent of recognition, guidance. Relevant Extent of recognition, guidance. Relevant 26JYN1 Relevant Relevant 48811 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Replacement recognition No. 2–163 ................. ........................ 2–165 ................. ........................ 2–167 ................. ........................ 2–168 ................. ........................ 2–169 ................. ........................ 2–170 ................. ........................ 2–171 ................. ........................ 2–172 ................. ........................ 2–173 ................. ........................ 2–174 ................. ........................ 2–175 ................. 2–228 2–176 ................. ........................ 2–177 ................. ........................ 2–180 ................. ........................ 2–189 ................. ........................ 2–190 ................. ........................ 2–191 ................. ........................ 2–197 ................. ........................ 2–198 ................. ........................ 2–204 ................. ........................ 2–206 ................. ........................ 2–207 ................. ........................ 2–213 ................. ........................ 2–214 ................. ........................ 2–215 ................. srobinson on DSK5SPTVN1PROD with NOTICES Old recognition No. 2–229 2–216 ................. 2–230 2–217 ................. 2–231 2–218 ................. ........................ 2–219 ................. ........................ VerDate Sep<11>2014 20:28 Jul 25, 2016 Title of standard 1 Change ANSI/AAMI/ISO 10993–9: 2009/(R) 2014 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products. ANSI/AMMI/ISO 10993–14:2001/(R) 2011, Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products form ceramics. ISO TS 10993–19 First edition 2006–06–01 Biological evaluation of medical devices—Part 19: Physio-chemical, morphological and topographical characterization of materials. ISO 10993–9 Second edition 2009–12–15 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products. ISO 10993–13 Second edition 2010–06–15, Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. ISO 10993–14 First edition 2001–11–15, Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics. ISO 10993–16 Second edition 2010–02–15, Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. ANSI/AAMI/ISO TIR 10993–19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical characterization of materials. ANSI/AAMI/ISO 10993–10:2010/(R) 2014 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization. ISO 10993–10 Third Edition 2010–08–01 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization. ISO 10993–3:2014 Third edition 2014–10–1 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. ISO 10993–11 Second edition 2006–08–15 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity. ISO 10993–06 Second edition 2007–04–15 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation. ANSI/AAMI/ISO 10993–16:2010/(R) 2014, Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables from medical devices. ASTM F895–11 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity. ANSI/AAMI/ISO 10993–13:2010/(R) 2014 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices. ISO 10993–12 Fourth edition 2012–07–01 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials. ASTM F749–13 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit. ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials. ASTM F720–13 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. ASTM F2148–13 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA). ASTM F756–13 Standard Practice for Assessment of Hemolytic Properties of Materials. ASTM F1904–14 Standard Practice for Testing the Biological Responses to Particles In Vivo. ASTM F619–14 Standard Practice for Extraction of Medical Plastics .. Reaffirmation, Extent of recognition, Relevant guidance. USP 39–NF34:2016 <87> Biological Reactivity test, In Vitro—Direct Contact Test. USP 39–NF34:2016 <87> Biological Reactivity Test, In Vitro—Elution Test. USP 39–NF34: 2016 <88> Biological Reactivity Tests, In Vivo ............ USP 39–NF34: 2016 <88> Biological Reactivity Tests In Vivo, Classification of Plastics—Intracutaneous Test. USP 39–NF34: 2016 <88> Biological Reactivity Tests In Vivo, Classification of Plastics—Systemic Injection Test. Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM Relevant guidance. Extent of recognition, guidance. Relevant Extent of recognition, guidance. Relevant Extent of recognition, guidance. Relevant Relevant guidance. Relevant guidance. Extent of recognition, guidance. Relevant Reaffirmation, Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Withdrawn and replaced with newer version. Extent of recognition, guidance. Extent of recognition, guidance. Relevant guidance. Relevant Relevant Extent of recognition, Relevant guidance. Reaffirmation, Extent of recognition, Relevant guidance. Extent of recognition, guidance. Relevant Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Extent of recognition, Relevant guidance. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. Change in title, Withdrawn and replaced with a newer version. Withdrawn; See 2–231. Withdrawn; See 2–231. 26JYN1 48812 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 2–220 ................. ........................ 2–221 ................. ........................ 2–222 ................. ........................ 2–223 ................. ........................ 2–225 ................. ........................ Title of standard 1 Change ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]. ANSI/AAMI/ISO 10993–2:2006/(R) 2014 Biological evaluation of medical devices—Part 2: Animal welfare requirements. ISO 10993–2 Second edition 2006–07–15 Biological evaluation of medical devices—Part 2: Animal welfare requirements. ASTM F2901–13, Standard guide for selecting tests to evaluate potential neurotoxicity of medical devices. ASTM F2567–06 (Reapproved 2010), Standard practice for testing for classical complement activation in serum by solid materials. Extent of recognition, guidance. Relevant Extent of recognition, guidance. Extent of recognition, guidance. Relevant guidance. Relevant Relevant Relevant guidance. B. Sterility 14–477 ............... 1 2–232 USP 39–NF34:2016 <151> Pyrogen Test ............................................. Transferred to Biocompatibility; Relevant guidance. 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 Title of standard 1 Recognition No. Reference No. and Date A. Biocompatibility 2–233 ...................... 2–234 ...................... 2–235 ...................... 2–236 ...................... 2–237 ...................... 2–238 ...................... 2–239 ...................... 2–240 ...................... 2–241 ...................... 2–242 ...................... 2–243 ...................... 1 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT). Biological Evaluation of Medical Devices—Part 4: Selection of tests for interaction with blood [Including Amendment 1(2006)]. Biological Evaluation of Medical Devices—Part 4: Selection of tests for interaction with blood [Including Amendment 1(2006)]. Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances. Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances. Biological evaluation of medical devices—Part 18: Chemical characterization of materials. Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices. Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices. Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants. Cardiovascular biological evaluation of medical devices—Guidance for absorbable implants. Biological evaluation of medical devices—Part 33: Guidance on tests to evaluate genotoxicity. ANSI/AAMI/ISO 10993–4:2002/(R)2013 & A1:2006/(R)2013. ISO 10994–4 Second edition 2002–10– 15 Amendment 1 2006–07–15. ANSI/AAMI/ISO 10993–17:2002/ (R)2012. ISO 10993–17 First edition 2002–12– 01. ANSI/AAMI BE 83: 2006/(R)2011. ANSI/AAMI/ISO TIR 10993–20:2006. ISO/TS 10993–20 First edition 2006– 08–01. ISO/TR 37137 First edition 2014–05– 15. ANSI/AAMI/ISO TR 37137: 2014. ISO/TR 10993–33:2015 First edition 2015–03–01. All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards srobinson on DSK5SPTVN1PROD with NOTICES F2382–04 (Reapproved 2010). 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 VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 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 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 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, E:\FR\FM\26JYN1.SGM 26JYN1 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 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. Food and Drug Administration [Docket No. FDA–2013–N–0190] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act AGENCY: VI. Electronic Access Food and Drug Administration, HHS. 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 srobinson on DSK5SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 25, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0671. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act (OMB Control Number 0910–0671)— Extension The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) was enacted on June 22, VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 48813 2009, amending the Federal Food, Drug, and Cosmetic Act and providing FDA with the authority to regulate tobacco products (Pub. L. 111–31; 123 Stat. 1776). Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act) (15 U.S.C. 4402), as amended by section 204 of the Tobacco Control Act, requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. Section 3(b)(3)(A) of the Smokeless Tobacco Act requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco ‘‘in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer’’ to, and approved by, FDA. This information collection-the submission to FDA of warning plans for smokeless tobacco products is statutorily mandated. The warning plans will be reviewed by FDA, as required by the Smokeless Tobacco Act, to determine whether the companies’ plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand of smokeless tobacco products comply with section 3 of the Smokeless Tobacco Act, as amended. Based on the Federal Trade Commission’s (FTC’s) previous experience with the submission of warning plans and FDA’s experience, FDA estimates that there are 52 companies affected by this information collection. To account for the entry of new smokeless tobacco companies that may be affected by this information collection, FDA is conservatively estimating the total number of annual respondents to this collection of information to be 100. When the FTC requested an extension of their approved warning plan information collection in 2007, based on over 20 years implementing the warning plan requirements and taking into account increased computerization and improvements in electronic communication, the FTC estimated submitting an initial plan would take 60 hours. Based on FDA’s experience over the past several years, FDA believes the estimate of 60 hours to complete an initial rotational plan continues to be reasonable. FDA estimates the burden of this collection of information as follows: E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48809-48813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17570]



[[Page 48809]]

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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