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

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: 066

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

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 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: 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,

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/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.

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.

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.

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.

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.

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

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.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

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

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