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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066

A Notice by the Food and Drug Administration on 08/24/2026

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Published Document: 2026-17229 (91 FR 54715)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2004-N-0451]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or the 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: 066” (Recognition List Number: 066), 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 August 24, 2026.

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 ( printed page 54716) 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: 066.” 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: 066.

  • 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 onhttps://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: 066 is available on the internet at https://www.fda.gov/​medical-devices/​division-standards-and-conformity-assessment/​federal-register-documents. See section IV for electronic access to the searchable database for the current list of FDA-recognized consensus standards, including Recognition List Number: 066 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: 066” to Terry Woods, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5612, 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, Rm. 5612, Silver Spring, MD 20993, 301-796-2503, .

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/​premarket-submissions-selecting-and-preparing-correct-submission/​division-standards-and-conformity-assessment.

II. Modifications to the List of Recognized Standards, Recognition List Number: 066

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: 066” 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 of this notice, 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: 066. ( printed page 54717)

Table 1—Modifications to the List of Recognized Standards
Old recognition No. Replacement recognition No. Title of standard 1 Change
A. Anesthesiology
1-157 1-203 ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026] Medical suction equipment—Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)] Withdrawn and replaced with newer version.
B. Biocompatibility
2-258 2-313 ISO 10993-1 Sixth edition 2025-11 Biological evaluation of medical devices—Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process Withdrawn and replaced with newer version.
2-289 2-314 ISO 10993-12 Fifth edition 2021-01 [Including AMD1:2025] Biological evaluation of medical devices—Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025)] Withdrawn and replaced with newer version.
C. Cardiovascular
3-173 3-204 ISO 5840-3 Second edition 2021-01 [Including AMD1:2025] Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques [Including: AMENDMENT 1 (2025)] Withdrawn and replaced with newer version.
3-174 3-205 ISO 5840-1 Second edition 2021-01 [Including AMD1:2025] Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements [Including: AMENDMENT 1 (2025)] Withdrawn and replaced with newer version.
3-175 3-206 ISO 5840-2 Second edition 2021-01 [Including AMD1:2025] Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes [Including: AMENDMENT 1 (2025)] Withdrawn and replaced with newer version.
3-189 3-207 ASTM F2942-25 Standard Guide for in vitro Axial, Bending, Torsional, and Compression Durability Testing of Vascular Stents and Vascular Stent-Grafts Withdrawn and replaced with newer version.
D. Dental/Ear, Nose, and Throat (ENT)
4-278 4-368 ISO 4823 Sixth edition 2025-06 Dentistry—Elastomeric impression and bite registration materials Withdrawn and replaced with newer version.
E. General I (Quality Systems/Risk Management) (QS/RM)
5-135 5-149 ISO 20417 Second edition 2026-03 Medical devices—Information to be supplied by the manufacturer Withdrawn and replaced with newer version.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
6-389 6-521 IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Extent of recognition. Withdrawn and replaced with newer version.
H. In Vitro Diagnostics (IVD)
No new entries at this time.
I. Materials
8-485 8-647 ASTM F3260-25 Standard Test Method for Determining the Flexural Stiffness of Medical Textiles Withdrawn and replaced with newer version.
8-520 8-648 ASTM F799-25 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) Withdrawn and replaced with newer version.
8-602 8-649 ASTM F2503-26 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment Withdrawn and replaced with newer version.
( printed page 54718)
J. Nanotechnology
18-16 18-25 ISO 21362 First edition 2026-02 Nanotechnologies—Analysis of nano-objects using asymmetrical flow and centrifugal field-flow fractionation Withdrawn and replaced with newer version.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9-133 9-152 ISO 23500-1 Second edition 2024-08 Preparation and quality management of fluids for haemodialysis and related therapies—Part 1: General requirements Extent of recognition. Withdrawn and replaced with newer version.
9-134 9-153 ISO 23500-2 Second edition 2024-07 Preparation and quality management of fluids for haemodialysis and related therapies—Part 2: Water treatment equipment for haemodialysis applications and related therapies Withdrawn and replaced with newer version.
9-135 9-154 ISO 23500-3 Second edition 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies—Part 3: Water for haemodialysis and related therapies Withdrawn and replaced with newer version.
9-136 9-155 ISO 23500-4 Second edition 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies—Part 4: Concentrates for haemodialysis and related therapies Extent of recognition. Withdrawn and replaced with newer version.
9-137 9-156 ISO 23500-5 Second edition 2024-04 Preparation and quality management of fluids for haemodialysis and related therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies Withdrawn and replaced with newer version.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11-175 ASTM F1582-98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants Withdrawn.
11-247 11-441 ASTM F2789-25 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices Withdrawn and replaced with newer version.
11-290 ISO 8828 Second edition 2014-11-15 Implants for surgery—Guidance on care and handling of orthopaedic implants Withdrawn.
11-319 11-442 ISO 7206-12 Second edition 2025-11 Implants for surgery—Partial and total hip joint prostheses—Part 12: Deformation test method for press-fit acetabular components Withdrawn and replaced with newer version.
11-346 11-443 ASTM F2706-25 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model Withdrawn and replaced with newer version.
11-353 11-444 ISO 18192-3 Second edition 2025-11 Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses Withdrawn and replaced with newer version.
11-371 11-445 ASTM F2009-25 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses Withdrawn and replaced with newer version.
11-398 11-446 ASTM F3574-25 Standard Test Methods for Sacroiliac Joint Fusion Devices Withdrawn and replaced with newer version.
O. Physical Medicine
16-166 16-240 ISO 7176-21 Third edition 2025-04 Wheelchairs—Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers Withdrawn and replaced with newer version.
P. Radiology
12-51, 12-303 12-386 IEC 63465 Edition 1.0 2026-01 Calibration and quality control in the use of radionuclide calibrators Withdrawn and replaced with newer version.
Q. Software/Informatics
13-106 13-157 IEEE Std. 11073-10207-2017 [Including Cor 1-2025] Standard Health informatics—Point of care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication [Including Corrigendum 1 (2025)] Withdrawn and replaced with newer version.
( printed page 54719)
13-142 FIRST CVSS 3.1 Common Vulnerability Scoring System version 3.1 Transition period extended.
R. Sterility
No new entries at this time.
S. Tissue Engineering
15-52 15-70 ASTM F2064-25 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications Withdrawn and replaced with newer version.
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: 066. These entries are of standards not previously recognized by FDA.

Table 2—New Entries to the List of Recognized Standards
Recognition No. Title of standard 1 Reference No. and date
A. Anesthesiology
No new entries at this time.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
No new entries at this time.
D. Dental/ENT
4-369 Periodontal Curettes, Dental Scalers and Excavators ANSI/ADA Standard No. 113-2015.
4-370 Casting Investments and Refractory Die Materials ANSI/ADA Standard No. 126-2015 (R2023).
4-371 Denture Adhesives ANSI/ADA Standard No. 135-2015 (R2020).
4-372 Dentistry—Dental Duplicating Material ANSI/ADA Standard No. 141-2013 (R2023).
4-373 Periodontal Probes—Dental Excavators—Discoid Type: General Requirements ANSI/ADA Standard No. 170-2019.
4-374 Dental Tweezers ANSI/ADA Standard No. 195-2021.
4-375 Spoons and Bone Curettes in Dentistry ANSI/ADA Standard No. 197-2021.
4-376 Dentistry—Dental explorer ISO 7492 Fourth edition 2019-03.
4-377 Dentistry—Extraction forceps—Part 1: General requirements ISO 9173-1 Third edition 2016-10.
4-378 Dentistry—Extraction forceps—Part 2: Designation ISO 9173-2 First edition 2010-05.
4-379 Dentistry—Extraction forceps—Part 3: Design ISO 9173-3 First edition 2014-05.
4-380 Dentistry—Magnetic attachments ISO 13017 Second edition 2020-07.
4-381 Dentistry—Dental furnace—Test method for temperature measurement with separate thermocouple ISO 13078 First edition 2013-02.
4-382 Dentistry—Dental furnace—Part 2: Test method for evaluation of furnace programme via firing glaze ISO 13078-2 First edition 2016-07.
4-383 Dentistry—Dental furnace—Part 3: Test method for the evaluation of high temperature sintering furnace measurement with a separate thermocouple ISO 13078-3 First edition 2023-05.
4-384 Periodontal curettes, dental scalers and excavators—Part 1: General requirements ISO 13397-1 First edition 1995-12.
4-385 Dentistry—Periodontal curettes, dental scalers and excavators—Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)] ISO 13397-2 Second edition 2005-06 [Including AMD1:2012].
4-386 Periodontal curettes, dental scalers and excavators—Part 3: Dental scalers—H-type ISO 13397-3 First edition 1996-09.
4-387 Dentistry—Periodontal curettes, dental scalers and excavators—Part 5: Jacquette scalers ISO 13397-5 First edition 2015-09.
4-388 Dentistry—Duplicating material ISO 14356 Second edition 2024-10.
4-389 Dentistry—Dental tweezers ISO 15098 Second edition 2024-07.
4-390 Dentistry—Refractory investment and die material ISO 15912 Second edition 2016-01.
( printed page 54720)
4-391 Dentistry—Minimal dental implant data set for clinical use ISO 16498 First edition 2013-07.
4-392 Dentistry—Coiled springs for use in orthodontics [Including AMENDMENT 1 (2020)] ISO 17254 First edition 2016-07 [Including AMD1:2020].
4-393 Dentistry—Reprocessable cartridge syringes for intraligamentary injections ISO 21533 Second edition 2018-01.
4-394 Dentistry—Periodontal probes—Part 1: General requirements ISO 21672-1 First edition 2012-04.
4-395 Dentistry—Materials for dental instruments—Part 1: Stainless steel ISO 21850-1 First edition 2020-04.
4-396 Dentistry—Spoons and bone curettes ISO 22570 First edition 2020-02.
4-397 Dentistry—Test methods for machining accuracy of computer-aided milling machines ISO 23298 First edition 2023-05.
4-398 Dentistry—Excavators ISO 23940 First edition 2021-04.
4-399 Dentistry—Bonding test between polymer teeth and denture base materials ISO TS 19736 First edition 2017-09.
E. General I (QS/RM)
No new entries at this time.
F. General II (ES/EMC)
No new entries at this time.
G. GH/GPS
No new entries at this time.
H. IVD
No new entries at this time.
I. Materials
8-650 Standard Guide for Content and Format of Test Report Summaries for Medical and Surgical Materials and Device Standards ASTM F3766-25.
J. Nanotechnology
No new entries at this time.
K. Neurology
17-23 Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION.
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
16-241 Wheelchairs—Part 31: Lithium-ion battery systems and chargers for powered wheelchairs—Requirements and test methods ISO 7176-31 First edition 2023-05.
P. Radiology
No new entries at this time.
Q. Software/Informatics
13-158 Open Mobile Health Data—Representation of Metadata, Sleep, and Physical Activity Measures IEEE Std 1752.1-2021.
( printed page 54721)
R. Sterility
No new entries at this time.
S. Tissue Engineering
No new entries at this time.
1 All standard titles in this table conform to the style requirements of the respective organizations.

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 . 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.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-17229 Filed 8-21-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-17229 (91 FR 54715)