89 FR 121 pgs. 52473-52479 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062
Type: NOTICEVolume: 89Number: 121Pages: 52473 - 52479
Pages: 52473, 52474, 52475, 52478Docket number: [Docket No. FDA-2004-N-0451]
FR document: [FR Doc. 2024-13777 Filed 6-21-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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: 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 June 24, 2024.
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 "Instructions").
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.
[top] • 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
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 FDA-recognized 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, 301-796-2503. 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-use-voluntary-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/federal-register-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/medical-devices/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-regulatory-assistance/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.
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| Old recognition No. | Replacement recognition No. | Title of standard? 1 | Change |
|---|---|---|---|
| A. Anesthesiology | |||
| 1-81 | 1-167 | CGA V-5:2019 Standard for Diameter Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) | Withdrawn and replaced with newer version. |
| 1-97 | 1-168 | CGA V-7.1:2021 Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases | Withdrawn and replaced with newer version. |
| 1-100 | 1-169 | CGA V-1:2021 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections | Withdrawn and replaced with newer version. |
| 1-101 | 1-170 | CGA C-9:2019 Standard Color Marking of Compressed Gas Containers for Medical Use | Withdrawn and replaced with newer version. |
| 1-103 | 1-171 | ISO 5367 Sixth edition 2023-07 Anaesthetic and respiratory equipment-Breathing sets and connectors | Extent of recognition. Withdrawn and replaced with newer version. |
| 1-126 | 1-172 | ISO 11712 Second edition 2023-11 Anaesthetic and respiratory equipment-Supralaryngeal airways and connectors | Withdrawn and replaced with newer version. |
| 1-134 | 1-173 | ISO 18562-1 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 1: Evaluation and testing within a risk management process | Withdrawn and replaced with newer version. |
| 1-135 | 1-174 | ISO 18562-2 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 2: Tests for emissions of particulate matter | Withdrawn and replaced with newer version. |
| 1-136 | 1-175 | ISO 18562-3 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 3: Tests for emissions of volatile organic substances | Withdrawn and replaced with newer version. |
| 1-137 | 1-176 | ISO 18562-4 Second edition 2024-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 4: Tests for leachables in condensate | Withdrawn and replaced with newer version. |
| 1-138 | 1-177 | ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment-Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | Withdrawn and replaced with newer version. |
| B. Biocompatibility | |||
| No new entries at this time. | |||
| C. Cardiovascular | |||
| 3-163 | 3-191 | ISO 18242 First edition 2016-09-01 [Including AMD1:2023] Cardiovascular implants and extracorporeal systems-Centrifugal blood pumps [Including AMENDMENT 1 (2023)] | Withdrawn and replaced with newer version. |
| D. Dental/Ear, Nose, and Throat (ENT) | |||
| 4-215 | 4-325 | ANSI/ADA Standard No. 96-2020 Dental Water-based Cements | Withdrawn and replaced with 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) | |||
| 19-19 | 19-50 | IEC TS 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment-Part 4-2: Guidance and interpretation-Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | Withdrawn and replaced with newer version. |
| G. General Hospital/General Plastic Surgery (GH/GPS) | |||
| 6-295 | ANSI AAMI BF7:2012 Blood transfusion microfilters | Withdrawn. | |
| 6-322 | 6-498 | ISO 10555-4 Third edition 2023-11 Intravascular catheters-Sterile and single-use catheters-Part 4: Balloon dilatation catheters | Withdrawn and replaced with newer version. |
| 6-408 | 6-499 | ISO 10555-1 Third edition 2023-11 Intravascular catheters-Sterile and single-use catheters-Part 1: General requirements | Withdrawn and replaced with newer version. |
| H. In Vitro Diagnostics (IVD) | |||
| No new entries at this time. | |||
| I. Materials | |||
| 8-159 | 8-611 | ISO 9584 Second edition 2023-10 Implants for surgery-Nondestructive testing-Radiographic examination of cast metallic surgical implants | Withdrawn and replaced with newer version. |
| 8-527 | 8-612 | ASTM F899-23 Standard Specification for Wrought Stainless Steels for Surgical Instruments | Withdrawn and replaced with newer version. |
| 8-580 | IEC 63145-20-10 Edition 1.0 2019-08 Eyewear display-Part 20-10: Fundamental measurement methods-Optical properties | Transferred. See 12-357. | |
| 8-581 | IEC 63145-20-20 Edition 1.0 2019-09 Eyewear display-Part 20-20: Fundamental measurement methods-Image quality | Transferred. See 12-358. | |
| 8-582 | IEC 63145-22-10 Edition 1.0 2020-01 Eyewear display-Part 22-10: Specific measurement methods for AR type-Optical properties | Transferred. See 12-359. | |
| J. Nanotechnology | |||
| No new entries at this time. | |||
| K. Neurology | |||
| 17-13 | 17-18 | IEEE Std 2010-2023 Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems | Withdrawn and replaced with newer version. |
| L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology) | |||
| No new entries at this time. | |||
| M. Ophthalmic | |||
| 10-56 | ANSI Z80.12-2007 (R2022) American National Standard for Ophthalmics-Multifocal Intraocular Lenses | Withdrawn with transition. See 10-135. | |
| 10-70 | 10-134 | ISO 10943 Fourth edition 2023-01-ophthalmic instruments-Indirect ophthalmoscopes | Withdrawn and replaced with newer version. |
| 10-125 | 10-135 | ISO 11979-7 Fifth edition 2024-01 Ophthalmic implants-Intraocular lenses-Part 7: Clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia | Withdrawn and replaced with newer version. |
| 10-126 | 10-136 | IEC 80601-2-58 Edition 3.0 2024-03 Medical electrical equipment-Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | Withdrawn and replaced with newer version. |
| N. Orthopedic | |||
| No new entries at this time. | |||
| O. Physical Medicine | |||
| No new entries at this time. | |||
| P. Radiology | |||
| 12-232 | 12-354 | NEMA MS 4-2023 Acoustic Noise Measurement Procedure for Magnetic Resonance Equipment | Withdrawn and replaced with newer version. |
| 12-242 | 12-355 | IEC 60601-2-57 Edition 2.0 2023-07 Medical Electrical Equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use | Withdrawn and replaced with newer version. |
| 12-268 | 12-356 | IEC 60601-2-22 Edition 4.0 2019-11 Medical electrical equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Withdrawn and replaced with newer version. |
| Q. Software/Informatics | |||
| 13-52 | 13-132 | ISO/IEEE 11073-10408 Second edition 2022-12 Health informatics-Point-of-care medical device communication-Part 10408: Device specialization-Thermometer | Withdrawn and replaced with newer version. |
| 13-53 | 13-133 | ISO/IEEE 11073-10415 Second edition 2022-12 Health informatics-Point-of-care medical device communication-Part 10415: Device specialization- Weighing scale | Withdrawn and replaced with newer version. |
| 13-54 | 13-134 | ISO/IEEE 11073-10404 Second edition 2022-12 Health informatics-Personal health device communication-Part 10404: Device specialization-Pulse oximeter | Withdrawn and replaced with newer version. |
| 13-57 | 13-135 | ISO/IEEE 11073-10407 Second edition 2022-12 Health informatics-Personal health device communication-Part 10407: Device Specialization-Blood pressure monitor | Withdrawn and replaced with newer version. |
| 13-113 | 13-136 | ISO/IEEE 11073-20601 Third Edition 2022-12 Health informatics-Personal health device communication-Part 20601: Application profile-Optimized exchange protocol | Withdrawn and replaced with newer version. |
| 13-114 | 13-137 | IEEE Std 11073-10101b-2023 Health informatics-Point-of-care medical device communication-Part 10101: Nomenclature | Withdrawn and replaced with newer version. |
| R. Sterility | |||
| 14-242 | 14-598 | ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments-Part 3: Test methods | Withdrawn and replaced with newer version. |
| 14-243 | ISO 14644-6 First edition 2007-07 Cleanrooms and associated controlled environments-Part 6: Vocabulary | Withdrawn. | |
| 14-277 | ISO TS 17665-2 First edition 2009-01 Sterilization of health care products-Moist heat-Part 2: Guidance on the application of ISO 17665-1 | Withdrawn with transition. See 14-601. | |
| 14-333 | ISO 17665-1 First edition 2006-08 Sterilization of health care products-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Withdrawn with transition. See 14-601. | |
| 14-389 | 14-599 | ISO 14644-9 Second edition Cleanrooms and associated controlled environments-Part 9: Assessment of surface cleanliness for particle concentration | Withdrawn and replaced with newer version. |
| 14-484 | 14-600 | ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Withdrawn and replaced with newer version. |
| 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. | |||
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.
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| Recognition No. | Title of standard? 1 | Reference No. and date |
|---|---|---|
| A. Anesthesiology | ||
| 1-178 | Anaesthetic and respiratory equipment-Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans | ISO 23747 Second edition 2015-08. |
| 1-179 | Anaesthetic and respiratory equipment-Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)] | ISO 26782 First edition 2009-07. |
| B. Biocompatibility | ||
| No new entries at this time. | ||
| C. Cardiovascular | ||
| 3-192 | Cardiovascular implants-Transcatheter cardiac occluders | ISO 22679 First edition 2021-11. |
| D. Dental/ENT | ||
| 4-326 | Dentistry-Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] | ISO 9687 Second edition 2015-02. |
| 4-327 | Dentistry-Graphical symbols for dental instruments | ISO 21531 First edition 2009-02. |
| E. General I (QS/RM) | ||
| 5-142 | Packaging-Distribution packaging-Graphical symbols for handling and storage of packages | ISO 780 Fifth edition 2015-12-01. |
| F. General II (ES/EMC) | ||
| No new entries at this time. | ||
| G. GH/GPS | ||
| 6-500 | Ultrasonics-Non-focusing short pressure pulse sources including ballistic pressure pulse sources-Characteristics of fields | IEC 63045 Edition 1.0 2020-05. |
| 6-501 | Plastic containers for intravenous injections | ISO 15747 Third edition 2018-09. |
| 6-502 | Injection systems for self-administration by paediatric patients-Requirements and guidelines for design | ISO 23217 First edition 2024-02. |
| H. IVD | ||
| 7-321 | Molecular Methods for Genotyping and Strain Typing of Infectious Organisms | CLSI MM24 1st Edition. |
| I. Materials | ||
| 8-613 | Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants | ASTM F2527-24. |
| 8-614 | Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials | ASTM F3456-22. |
| 8-615 | Additive manufacturing of metals-Qualification principles-Part 1: General qualification of operators | ISO/ASTM 52926-1 First edition 2023-11. |
| 8-616 | Additive manufacturing of metals-Qualification principles-Part 2: Qualification of operators for PBF-LB | ISO/ASTM 52926-2 First edition 2023-11. |
| 8-617 | Additive manufacturing of metals-Qualification principles-Part 3: Qualification of operators for PBF-EB | ISO/ASTM 52926-3 First edition 2023-11. |
| J. Nanotechnology | ||
| No new entries at this time. | ||
| K. Neurology | ||
| 17-19 | Medical electrical equipment-Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment | ISO 80601-2-85 Edition 1.0 2021-03. |
| 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 | ||
| No new entries at this time. | ||
| P. Radiology | ||
| 12-357 | Eyewear display-Part 20-10: Fundamental measurement methods-Optical properties | IEC 63145-20-10 Edition 1.0 2019-08. |
| 12-358 | Eyewear display-Part 20-20: Fundamental measurement methods-Image quality | IEC 63145-20-20 Edition 1.0 2019-09. |
| 12-359 | Eyewear display-Part 22-10: Specific measurement methods for AR type-Optical properties | IEC 63145-22-10 Edition 1.0 2020-01. |
| 12-360 | Eyewear display-Part 10: Specifications | IEC 63145-10 Edition 1.0 2023-09. |
| 12-361 | Information Display Measurements Standard | ICDM IDMS Version 1.2 May 2023. |
| Q. Software/Informatics | ||
| 13-138 | Health Informatics-Device Interoperability Part 10700: Point-of-Care Medical Device Communication-Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System | IEEE Std 11073-10700-2022. |
| 13-139 | Health informatics-Device interoperability-Part 10206: Personal health device communication-Abstract Content Information Model | IEEE Std 11073-10206-2022. |
| R. Sterility | ||
| 14-601 | Sterilization of health care products-Moist heat-Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO 17665 First edition 2024-03. |
| 14-602 | Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers | AAMI TIR12:2020/(R)2023. |
| 14-603 | Product adoption and process equivalence for ethylene oxide sterilization | AAMI TIR28:2016/(R)2020. |
| 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. | ||
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-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13777 Filed 6-21-24; 8:45 am]
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