Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 065

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: 065

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: 065” (Recognition List Number: 065), 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 February 19, 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: 065.” 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: 065.

• 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: 065 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: 065 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: 065” 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, 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: 065

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: 065” 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: 065.

Table 1—Modifications to the List of Recognized Standards

Old

Recognition No.

Replacement

Recognition No.

Title of standard

1

Change

A. Anesthesiology

1-106

1-197

ISO 17510 Second Edition 2025-11 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories

Withdrawn and replaced with newer version.

1-149

1-198

ISO 7376 Third edition 2020-08 [Including AMD1:2025] Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubation—Amendment 1: Clarification of optical output and illumination requirements [Including Amendment 1 (2025)]

Withdrawn and replaced with newer version.

1-151

1-199

ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment—Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

Withdrawn and replaced with newer version.

B. Biocompatibility

2-141

2-308

ASTM F1984-25 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

Withdrawn and replaced with newer version.

2-155

ASTM F2147-01 (Reapproved 2016) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

Withdrawn.

2-189

2-309

ASTM F895-25 Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

Withdrawn and replaced with newer version.

2-244

2-310

ASTM F748-25 Standard Practice for Selecting Biological Test Methods for Materials and Devices

Withdrawn and replaced with newer version.

2-248

2-311

ISO 10993-4 Third edition 2017-04 Amendment 1 2025-1 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood [including AMENDMENT 1 (2025)]

Withdrawn and replaced with newer version.

2-256

2-312

ASTM F720-24 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

Withdrawn and replaced with newer version.

C. Cardiovascular

3-102

3-201

IEC 60601-2-31 Edition 3.0 2020-01 Medical electrical equipment—Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Withdrawn and replaced with newer version.

3-115

3-202

IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment—Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Withdrawn and replaced with newer version.

D. Dental/Ear, Nose, and Throat (ENT)

4-153

4-348

ISO 9917-1 Third edition 2025-05 Dentistry—Water-based cements—Part 1: Acid-base cements

Withdrawn and replaced with newer version.

4-271

4-349

ANSI/ADA Standard No. 34-2025 Dentistry—Cartridge Syringes

Withdrawn and replaced with newer version.

4-275

4-350

ASA/ANSI S3.6-2025 American National Standard Specification for Audiometers

Withdrawn and replaced with newer version.

4-309

4-351

ISO 6877 Fourth edition 2025-08 Dentistry—Endodontic obturating materials

Withdrawn and replaced with newer version.

4-312

4-352

ASA/ANSI S3.35-2025 American National Standard Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions

Withdrawn and replaced with newer version.

4-316

4-353

ISO 20127 Third edition 2025-05 Dentistry—Physical properties of powered toothbrushes

Withdrawn and replaced with newer version.

4-319

4-354

ISO 17730 Third edition 2025-09 Dentistry—Fluoride varnishes

Withdrawn and replaced with newer version.

4-336

4-355

ISO 18397 Second edition 2025-07 Dentistry—Powered scalers

Withdrawn and replaced with newer version.

E. General I (Quality Systems/Risk Management) (QS/RM)

5-108

5-146

ISO 80369-6 Second edition 2025-05 Small bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neural applications

Withdrawn and replaced with newer version.

5-121

5-147

ISO 80369-1 Third edition 2025-10 Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements

Withdrawn and replaced with newer version.

5-134

5-148

ISO 15223-1 Fourth edition 2021-07 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements [Including Amendment 1 (2025)]

Withdrawn and replaced with newer version.

F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)

19-43

19-57

IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 2-6: Particular requirements—In vitro diagnostic (IVD) medical equipment

Withdrawn and replaced with newer version.

G. General Hospital/General Plastic Surgery (GH/GPS)

6-384

6-514

ISO 1135-4 Seventh edition 2025-05 Transfusion equipment for medical use—Part 4: Transfusion sets for single use, gravity feed

Withdrawn and replaced with newer version.

6-411

6-515

ASTM D6499-24 Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

Withdrawn and replaced with newer version.

6-439

ISO 7886-2 Second edition 2020-04 Sterile hypodermic syringes for single use—Part 2—Syringes for use with power-driven syringe pumps

Extent of recognition.

6-448

6-516

ASTM F2407/F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

Withdrawn and replaced with newer version.

6-484

6-517

ASTM F3502-25 Standard Specification for Barrier Face Coverings

Withdrawn and replaced with newer version.

6-491

6-518

ASTM F1670/F1670M-24a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Withdrawn and replaced with newer version.

6-493

6-519

ASTM F2101-25 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

Withdrawn and replaced with newer version.

6-494

6-520

ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-239

7-346

CLSI EP32 2nd Edition Implementation of Metrological Traceability in Laboratory Medicine

Withdrawn and replaced with newer version.

7-268

7-347

CLSI EP21 2nd Edition Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures

Withdrawn and replaced with newer version.

7-284

7-348

CLSI EP37 1st Edition Supplemental Tables for Interference Testing in Clinical Chemistry

Withdrawn and replaced with newer version.

7-298

7-349

CLSI EP35 1st Edition Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures

Withdrawn and replaced with newer version.

I. Materials

8-179

8-628

ASTM F754-24 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Withdrawn and replaced with newer version.

8-356

8-629

ASTM F67-24 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

Withdrawn and replaced with newer version.

8-399

8-630

ASTM F90-24 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

Withdrawn and replaced with newer version.

8-400

8-631

ASTM F1854-25 Standard Test Method for Serological Evaluation of Porous Coatings on Medical Implants using Digital Images

Withdrawn and replaced with newer version.

8-449

8-632

ASTM F1058-25 Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)

Withdrawn and replaced with newer version.

8-455

8-633

ASTM F2902-24 Standard Guide for Assessment of Absorbable Polymeric Implants

Withdrawn and replaced with newer version.

8-484

8-634

ASTM F2066-23 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Withdrawn and replaced with newer version.

8-498

8-635

ASTM F75-23 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Withdrawn and replaced with newer version.

8-507

8-636

ASTM F688-25 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Withdrawn and replaced with newer version.

8-508

8-637

ASTM F2579-24 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

Withdrawn and replaced with newer version.

8-521

8-638

ASTM F2313-24 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

Withdrawn and replaced with newer version.

8-540

8-639

ASTM F1091-25 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS R30605)

Withdrawn and replaced with newer version.

8-544

8-640

ASTM F961-25 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

Withdrawn and replaced with newer version.

8-547

8-641

ASTM F629-24 Standard Practice for Radiography of Cast Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-551

8-642

ASTM F2895-24 Standard Practice for Digital Radiography of Cast Metallic Implants

Withdrawn and replaced with newer version.

8-574

8-643

ASTM F2820-24 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-578

8-644

ASTM F2848-25 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns

Withdrawn and replaced with newer version.

8-589

8-645

ASTM F1925-24 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

Withdrawn and replaced with newer version.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)

No new entries at this time.

M. Ophthalmic

10-85

10-139

ISO 11980 Fourth edition 2025-06 Ophthalmic optics—Contact lenses and contact lens care products—Requirements and guidance for clinical investigations

Withdrawn and replaced with newer version.

N. Orthopedic

11-185

11-423

ASTM F2267-24 Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Withdrawn and replaced with newer version.

11-197

11-424

ASTM F983-24 Standard Practice for Permanent Marking of Orthopaedic Implant Components

Withdrawn and replaced with newer version.

11-199

11-425

ASTM F565-21 Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Withdrawn and replaced with newer version.

11-283

11-426

ASTM F2943-25 Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants

Withdrawn and replaced with newer version.

11-316

11-427

ASTM F1264-24 Standard Specification and Test Methods for Intramedullary Fixation Devices

Withdrawn and replaced with newer version.

11-322

11-428

ASTM F1541-24 Standard Specification and Test Methods for External Skeletal Fixation Devices

Withdrawn and replaced with newer version.

11-324

11-429

ASTM F366-24 Standard Specification for Fixation Pins and Wires

Withdrawn and replaced with newer version.

11-325

11-430

ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples

Withdrawn and replaced with newer version.

11-326

11-431

ASTM F384-24 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Withdrawn and replaced with newer version.

11-329

11-432

ASTM F2180-24 Standard Specification for Metallic Implantable Strands and Cables

Withdrawn and replaced with newer version.

11-330

11-433

ASTM F2028-25a Standard Test Methods for Dynamic Evaluation of Glenoid Loosening

Withdrawn and replaced with newer version.

11-340

11-434

ASTM F3018-25 Standard Guide for Assessment of Hard-on-Hard Articulation in Total Hip Joint Replacement and Resurfacing Hip Joint Replacement

Withdrawn and replaced with newer version.

11-369

11-435

ASTM F3292-25 Standard Practice for Inspection of Spinal Implants Undergoing Testing

Withdrawn and replaced with newer version.

11-374

11-436

ISO 7207-2 Third edition 2025-08 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials

Withdrawn and replaced with newer version.

11-376

11-437

ASTM F2033-25 Standard Specification for Hip Joint Replacement Bearing Surfaces

Withdrawn and replaced with newer version.

11-378

11-438

ASTM F2502-24 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

Withdrawn and replaced with newer version.

O. Physical Medicine

16-203

16-237

ASME A18.1:2023 Safety Standard for Platform Lifts and Stairway Chairlifts

Withdrawn and replaced with newer version.

P. Radiology

12-361

12-384

ICDM IDMS Version 1.3 May 31, 2025 Information Display Measurements Standard

Withdrawn and replaced with newer version.

12-363

12-385

NEMA PS 3.1-3.20 2025d Digital Imaging and Communications in Medicine (DICOM) Set

Withdrawn and replaced with newer version.

Q. Software/Informatics

13-69

13-150

IEEE Std 11073-10472-2023 Health informatics—Device Interoperability—Part 10472: Personal Health Device Communication—Device Specialization—Medication Monitor

Withdrawn and replaced with newer version.

13-92, 13-55

13-151

IEEE Std 11073-10421-2023 Health Informatics—Device Interoperability—Part 10421: Personal Health Device Communication—Device Specialization—Peak expiratory flow monitor (peak flow)

Withdrawn and replaced with newer version.

R. Sterility

No new entries at this time.

S. Tissue Engineering

15-67

15-68

ASTM F2212-25 Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

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: 065. 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 number and date

A. Anesthesiology

1-200

Anaesthetic and respiratory equipment—Part 2: Video laryngoscopes

ISO 7376-2 First edition 2025-09.

1-201

Lung ventilators and related equipment—Vocabulary and semantics—Part 2: High frequency and jet ventilation

ISO 19223-2 First edition 2025-04.

1-202

Lung ventilators and related equipment—Vocabulary and semantics—Part 3: Respiratory care

ISO 19223-3 First edition 2025-09.

B. Biocompatibility

No new entries at this time.

C. Cardiovascular

3-203

Medical electrical equipment—Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION.

D. Dental/ENT

4-356

Dentistry—Orthodontic Wires

ANSI/ADA Standard No. 32-2024.

4-357

Double-Pointed, Parenteral, Single Use Needles for Dentistry

ANSI/ADA Standard No. 54-1986 (R2024).

4-358

Endodontics Instruments—Enlargers

ANSI/ADA Standard No. 95-2020.

4-359

Dentistry—Coiled Springs for Use in Orthodontics

ANSI/ADA Standard No. 159-2024.

4-360

Dentistry—Endodontic instruments—Part 1: General requirements

ISO 3630-1 Third edition 2019-08.

4-361

Dentistry—Endodontic instruments—Part 2: Enlargers

ISO 3630-2 Fourth edition 2023-02.

4-362

Dentistry—Endodontic instruments—Part 3: Compactors

ISO 3630-3 Third edition 2021-06 Corrected version 2023-05.

4-363

Dentistry—Endodontic instruments—Part 5: Shaping and cleaning instruments

ISO 3630-5 Second edition 2020-08.

4-364

Dentistry—Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials

ISO 3990 First edition 2023-07.

4-365

Dentistry—Gypsum products

ISO 6873 Third edition 2013-04.

4-366

Dentistry—Endodontic absorbent points

ISO 7551 Second edition 2023-05.

4-367

Dentistry—Cartridge syringes

ISO 9997 Third edition 2020-01.

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

7-351

Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures

CLSI EP46 1st Edition.

I. Materials

8-646

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications

ASTM F624-25.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. OB-Gyn/G/Urology

No new entries at this time.

M. Ophthalmic

10-140

American National Standard for Ophthalmics—Prescription Ophthalmic Lenses—Recommendations

ANSI Z80.1-2020.

10-141

Ophthalmic optics—Contact lenses and contact lens care products—Labelling [Including Amendment 1 (2020)]

ISO 11978 Third edition 2017-08 [Including AMD1:2020].

N. Orthopedic

11-439

Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation

ASTM F3437-23.

11-440

Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles

ASTM F3738-25.

O. Physical Medicine

16-238

Assistive products for walking manipulated by both arms—Requirements and test methods Part 1: Walking frames

ISO 11199-1 Second edition 2021-05.

16-239

Assistive products for walking manipulated by both arms—Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]

ISO 11199-2 Third edition 2021-07 [Including AMD1:2024].

P. Radiology

No new entries at this time.

Q. Software/Informatics

13-152

Health informatics—Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics

ISO TS 5615:2025.

13-153

Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices

AAMI CR515.

13-154

Health informatics—Device Interoperability—Part 10429: Personal Health Device Communication—Device Specialization—Spirometry

IEEE Std 11073-10429-2022.

13-155

Health informatics—Device Interoperability Part 10442: Personal health device communication—Device specialization—Strength fitness equipment

IEEE Std 11073-10442-2023.

13-156

Health Informatics—Device Interoperability—Part 10471: Personal Health Device Communication—Device Specialization—Independent Living Activity Hub

IEEE Std 11073-10471-2023.

R. Sterility

14-612

Bacterial Endotoxins Test Using Recombinant Reagents

USP-NF <86> M16015_02_01.

S. Tissue Engineering

15-69

Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture

ASTM F2944-20.

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. 2026-03310 Filed 2-18-26; 8:45 am]

BILLING CODE 4164-01-P