4164-01-P 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: 062 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: 062†(Recognition List Number: 062), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER]. ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions†and “Instructionsâ€). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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: 062.†Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,†publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. 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: 062. • 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search†box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. An electronic copy of Recognition List Number: 062 is available on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm . See section IV for electronic access to the searchable database for the current list of FDArecognized consensus standards, including Recognition List Number: 062 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: 062†to Terry Woods, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-7962503. Send one self-addressed adhesive label to assist that office in processing your request or fax your request to 301-847-8144. FOR FURTHER INFORMATION CONTACT: Terry Woods, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-2503, CDRHStandardsStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 of the FD&C Act 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 the Federal Register of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.†The guidance describes how FDA has implemented its standards recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-usevoluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the initial list of recognized standards, as published in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federalregister-documents. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website HTML and PDF versions of the list of FDA Recognized Consensus Standards, available at https://www.fda.gov/medicaldevices/standards-and-conformity-assessment-program/federal-register-documents. Additional information on the Agency’s Division of Standards and Conformity Assessment is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program. II. Modifications to the List of Recognized Standards, Recognition List Number: 062 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency’s searchable database. FDA is using the term “Recognition List Number: 062†to identify the 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 new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 062. Old Recognition No. 1-81 1-97 1-100 1-101 1-103 1-126 Table 1.--Modifications to the List of Recognized Standards Replacement Title of Standard1 Change Recognition No. A. Anesthesiology 1-167 CGA V-5:2019 Standard for Diameter Index Safety Withdrawn and replaced with System (Noninterchangeable Low Pressure newer version. Connections for Medical Gas Applications). 1-168 CGA V-7.1:2021 Standard Method of Determining Withdrawn and replaced with Cylinder Valve Outlet Connections for Medical newer version. Gases. 1-169 CGA V-1:2021 Standard for Compressed Gas Withdrawn and replaced with Cylinder Valve Outlet and Inlet Connections. newer version. 1-170 CGA C-9:2019 Standard Color Marking of Withdrawn and replaced with Compressed Gas Containers for Medical Use. newer version. 1-171 ISO 5367 Sixth edition 2023-07 Anaesthetic and Extent of recognition. respiratory equipment--Breathing sets and Withdrawn and replaced with connectors. newer version. 1-172 ISO 11712 Second edition 2023-11 Anaesthetic Withdrawn and replaced with and respiratory equipment--Supralaryngeal airways newer version. and connectors. Old Recognition No. 1-134 1-135 1-136 1-137 1-138 3-163 4-215 19-19 6-295 6-322 6-408 8-159 8-527 Table 1.--Modifications to the List of Recognized Standards Replacement Title of Standard1 Change Recognition No. 1-173 ISO 18562-1 Second edition 2024-03 Withdrawn and replaced with Biocompatibility evaluation of breathing gas newer version. pathways in healthcare applications--Part 1: Evaluation and testing within a risk management process. 1-174 ISO 18562-2 Second edition 2024-03 Withdrawn and replaced with Biocompatibility evaluation of breathing gas newer version. pathways in healthcare applications--Part 2: Tests for emissions of particulate matter. 1-175 ISO 18562-3 Second edition 2024-03 Withdrawn and replaced with Biocompatibility evaluation of breathing gas newer version. pathways in healthcare applications--Part 3: Tests for emissions of volatile organic substances. 1-176 ISO 18562-4 Second edition 2024-03 Withdrawn and replaced with Biocompatibility evaluation of breathing gas newer version. pathways in healthcare applications--Part 4: Tests for leachables in condensate. 1-177 ISO 80601-2-74 Second edition 2021-07 Medical Withdrawn and replaced with electrical equipment-Part 2-74: Particular newer version. requirements for basic safety and essential performance of respiratory humidifying equipment. B. Biocompatibility No new entries at this time. C. Cardiovascular 3-191 ISO 18242 First edition 2016-09-01 [Including Withdrawn and replaced with AMD1:2023] Cardiovascular implants and newer version. extracorporeal systems--Centrifugal blood pumps [Including AMENDMENT 1 (2023)]. D. Dental/Ear, Nose, and Throat (ENT) 4-325 ANSI/ADA Standard No. 96-2020 Dental WaterWithdrawn and replaced with based Cements. newer version. E. General I (Quality Systems/Risk Management) (QS/RM) No new entries at this time. F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19-50 IEC TS 60601-4-2 Edition 1.0 2024-03 Medical Withdrawn and replaced with electrical equipment--Part 4-2: Guidance and newer version. interpretation--Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. G. General Hospital/General Plastic Surgery (GH/GPS) ANSI AAMI BF7:2012 Blood transfusion Withdrawn. microfilters. 6-498 ISO 10555-4 Third edition 2023-11 Intravascular Withdrawn and replaced with catheters--Sterile and single-use catheters--Part 4: newer version. Balloon dilatation catheters. 6-499 ISO 10555-1 Third edition 2023-11 Intravascular Withdrawn and replaced with catheters--Sterile and single-use catheters--Part 1: newer version. General requirements. H. In Vitro Diagnostics (IVD) No new entries at this time. I. Materials 8-611 ISO 9584 Second edition 2023-10 Implants for Withdrawn and replaced with surgery--Nondestructive testing--Radiographic newer version. examination of cast metallic surgical implants. 8-612 ASTM F899-23 Standard Specification for Withdrawn and replaced with Wrought Stainless Steels for Surgical Instruments. newer version. Old Recognition No. 8-580 8-581 8-582 17-13 10-56 10-70 10-125 10-126 12-232 12-242 12-268 13-52 Table 1.--Modifications to the List of Recognized Standards Replacement Title of Standard1 Change Recognition No. IEC 63145-20-10 Edition 1.0 2019-08 Eyewear Transferred. See 12-357. display--Part 20-10: Fundamental measurement methods--Optical properties. IEC 63145-20-20 Edition 1.0 2019-09 Eyewear Transferred. See 12-358. display--Part 20-20: Fundamental measurement methods--Image quality. IEC 63145-22-10 Edition 1.0 2020-01 Eyewear Transferred. See 12-359. display--Part 22-10: Specific measurement methods for AR type--Optical properties. J. Nanotechnology No new entries at this time. K. Neurology 17-18 IEEE Std 2010-2023 Recommended Practice for Withdrawn and replaced with Electroencephalography (EEG) Neurofeedback newer version. Systems. L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) No new entries at this time. M. Ophthalmic ANSI Z80.12-2007 (R2022) American National Withdrawn with transition. Standard for Ophthalmics--Multifocal Intraocular See 10-135. Lenses. 10-134 ISO 10943 Fourth edition 2023-01--ophthalmic Withdrawn and replaced with instruments--Indirect ophthalmoscopes. newer version. 10-135 ISO 11979-7 Fifth edition 2024-01 Ophthalmic Withdrawn and replaced with implants--Intraocular lenses--Part 7: Clinical newer version. investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. 10-136 IEC 80601-2-58 Edition 3.0 2024-03 Medical Withdrawn and replaced with electrical equipment--Part 2-58: Particular newer version. requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery. N. Orthopedic No new entries at this time. O. Physical Medicine No new entries at this time. P. Radiology 12-354 NEMA MS 4-2023 Acoustic Noise Measurement Withdrawn and replaced with Procedure for Magnetic Resonance Equipment. newer version. 12-355 IEC 60601-2-57 Edition 2.0 2023-07 Medical Withdrawn and replaced with Electrical Equipment--Part 2-57: Particular newer version. requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use. 12-356 IEC 60601-2-22 Edition 4.0 2019-11 Medical Withdrawn and replaced with electrical equipment--Part 2-22: Particular newer version. requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. Q. Software/Informatics 13-132 ISO/IEEE 11073-10408 Second edition 2022-12 Withdrawn and replaced with newer version. Health informatics--Point-of-care medical device communication--Part 10408: Device specialization-Thermometer. Table 1.--Modifications to the List of Recognized Standards Replacement Title of Standard1 Change Recognition No. 13-133 ISO/IEEE 11073-10415 Second edition 2022-12 Withdrawn and replaced with newer version. Health informatics--Point-of-care medical device communication--Part 10415: Device specializationWeighing scale. 13-54 13-134 ISO/IEEE 11073-10404 Second edition 2022-12 Withdrawn and replaced with newer version. Health informatics--Personal health device communication--Part 10404: Device specialization-Pulse oximeter. 13-57 13-135 ISO/IEEE 11073-10407 Second edition 2022-12 Withdrawn and replaced with newer version. Health informatics--Personal health device communication--Part 10407: Device Specialization--Blood pressure monitor. 13-113 13-136 ISO/IEEE 11073-20601 Third Edition 2022-12 Withdrawn and replaced with Health informatics--Personal health device newer version. communication--Part 20601: Application profile-Optimized exchange protocol. 13-114 13-137 IEEE Std 11073-10101b-2023 Health informatics-- Withdrawn and replaced with Point-of-care medical device communication--Part newer version. 10101: Nomenclature. R. Sterility 14-242 14-598 ISO 14644-3 Second edition 2020-06 Cleanrooms Withdrawn and replaced with and associated controlled environments--Part 3: newer version. Test methods. 14-243 ISO 14644-6 First edition 2007-07 Cleanrooms and Withdrawn. associated controlled environments--Part 6: Vocabulary. 14-277 ISO TS 17665-2 First edition 2009-01 Sterilization Withdrawn with transition. of health care products--Moist heat--Part 2: See 14-601. Guidance on the application of ISO 17665-1. 14-333 ISO 17665-1 First edition 2006-08 Sterilization of Withdrawn with transition. health care products--Moist heat--Part 1: See 14-601. Requirements for the development, validation and routine control of a sterilization process for medical devices. 14-389 14-599 ISO 14644-9 Second edition Cleanrooms and Withdrawn and replaced with associated controlled environments--Part 9: newer version. Assessment of surface cleanliness for particle concentration. 14-484 14-600 ASTM F1929-23 Standard Test Method for Withdrawn and replaced with Detecting Seal Leaks in Porous Medical Packaging newer version. by Dye Penetration. S. Tissue Engineering No new entries at this time. 1 All standard titles in this table conform to the style requirements of the respective organizations. Old Recognition No. 13-53 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: 062. These entries are of standards not previously recognized by FDA. Table 2.--New Entries to the List of Recognized Standards Recognition No. 1-178 1-179 3-192 4-326 4-327 5-142 6-500 6-501 6-502 7-321 8-613 8-614 8-615 8-616 8-617 17-19 Title of Standard1 A. Anesthesiology Anaesthetic and respiratory equipment--Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. Anaesthetic and respiratory equipment--Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)]. B. Biocompatibility No new entries at this time. C. Cardiovascular Cardiovascular implants--Transcatheter cardiac occluders. D. Dental/ENT Dentistry--Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)]. Dentistry--Graphical symbols for dental instruments. E. General I (QS/RM) Packaging--Distribution packaging--Graphical symbols for handling and storage of packages. F. General II (ES/EMC) No new entries at this time. G. GH/GPS Ultrasonics--Non-focusing short pressure pulse sources including ballistic pressure pulse sources--Characteristics of fields. Plastic containers for intravenous injections. Injection systems for self-administration by paediatric patients-Requirements and guidelines for design. H. IVD Molecular Methods for Genotyping and Strain Typing of Infectious Organisms. I. Materials Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants. Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials. Additive manufacturing of metals--Qualification principles--Part 1: General qualification of operators. Additive manufacturing of metals--Qualification principles--Part 2: Qualification of operators for PBF-LB. Additive manufacturing of metals--Qualification principles--Part 3: Qualification of operators for PBF-EB. J. Nanotechnology No new entries at this time. K. Neurology Medical electrical equipment--Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment. L. OB-Gyn/G/Urology No new entries at this time. M. Ophthalmic No new entries at this time. N. Orthopedic No new entries at this time. O. Physical Medicine Reference No. and Date ISO 23747 Second edition 2015-08. ISO 26782 First edition 200907. ISO 22679 First edition 202111. ISO 9687 Second edition 2015-02. ISO 21531 First edition 200902. ISO 780 Fifth edition 2015-1201. IEC 63045 Edition 1.0 202005. ISO 15747 Third edition 201809. ISO 23217 First edition 202402. CLSI MM24 1st Edition. ASTM F2527-24. ASTM F3456-22. ISO/ASTM 52926-1 First edition 2023-11. ISO/ASTM 52926-2 First edition 2023-11. ISO/ASTM 52926-3 First edition 2023-11. ISO 80601-2-85 Edition 1.0 2021-03. Table 2.--New Entries to the List of Recognized Standards Recognition No. 12-360 Title of Standard1 No new entries at this time. P. Radiology Eyewear display--Part 20-10: Fundamental measurement methods--Optical properties. Eyewear display--Part 20-20: Fundamental measurement methods--Image quality. Eyewear display--Part 22-10: Specific measurement methods for AR type--Optical properties. Eyewear display--Part 10: Specifications. 12-361 Information Display Measurements Standard. 12-357 12-358 12-359 Reference No. and Date IEC 63145-20-10 Edition 1.0 2019-08. IEC 63145-20-20 Edition 1.0 2019-09. IEC 63145-22-10 Edition 1.0 2020-01. IEC 63145-10 Edition 1.0 2023-09. ICDM IDMS Version 1.2 May 2023. Q. Software/Informatics Health Informatics--Device Interoperability Part 10700: IEEE Std 11073â€10700â€2022. Pointâ€ofâ€Care Medical Device Communication--Standard for Base Requirements for Participants in a Serviceâ€Oriented Device Connectivity (SDC) System. 13-139 Health informatics--Device interoperability--Part 10206: Personal IEEE Std 11073-10206-2022. health device communication--Abstract Content Information Model. R. Sterility 14-601 Sterilization of health care products--Moist heat--Requirements ISO 17665 First edition 2024for the development, validation and routine control of a 03. sterilization process for medical devices. 14-602 Designing, testing, and labeling medical devices intended for AAMI TIR12:2020/(R)2023. processing by health care facilities: A guide for device manufacturers. 14-603 Product adoption and process equivalence for ethylene oxide AAMI TIR28:2016/(R)2020. sterilization. S. Tissue Engineering No new entries at this time. 1 All standard titles in this table conform to the style requirements of the respective organizations. 13-138 IV. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the Federal Register). 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. 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 CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program#process. Dated: June 18, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13777 Filed: 6/21/2024 8:45 am; Publication Date: 6/24/2024]