Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061

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: 061

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: 061” (Recognition List Number: 061), 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 March 1, 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: 061.” 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: 061.

• 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: 061 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: 061 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: 061” 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 Standards and Conformity Assessment Program 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: 061

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: 061” 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: 061.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement

recognition

No.

Title of standard

1

Change

A. Anesthesiology

1-73

1-162

ISO 10651-4 Second edition 2023-03 Lung ventilators—Part 4: Particular requirements for user-powered resuscitators

Withdrawn and replaced with newer version.

1-105

1-163

ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment—Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Withdrawn and replaced with newer version.

1-118

1-164

ISO 5361 Fourth edition 2023-11 Anaesthetic and respiratory equipment—Tracheal tubes and connectors

Withdrawn and replaced with newer version.

1-141

1-165

ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment—Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

Withdrawn and replaced with newer version.

B. Biocompatibility

2-94

2-302

ASTM F981-23 Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

Withdrawn and replaced with newer version.

2-237

2-303

ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices—Part 17: Toxicological risk assessment of medical device constituents

Withdrawn and replaced with newer version.

C. Cardiovascular

3-105

IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

Extent of recognition.

3-126

IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]

Extent of recognition.

3-138

3-189

ASTM F2942-19 Standard Guide for

in vitro

Axial, Bending, and Torsional Durability Testing of Vascular Stents

Withdrawn and replaced with newer version.

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

4-137

4-309

ISO 6877 Third edition 2021-09 Dentistry—Endodontic obturating materials

Withdrawn and replaced with newer version.

4-151

4-310

ISO 22112 Second edition 2017-08 Dentistry—Artificial teeth for dental prostheses

Withdrawn and replaced with newer version.

4-188

4-311

ISO 9917-2 Third edition 2017-09 Dentistry—Water-based cements—Part 2: Resin-modified cements

Withdrawn and replaced with newer version.

4-190

4-312

ANSI/ASA S3.35-2021 American National Standard Method for Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions

Withdrawn and replaced with newer version.

4-218

4-313

ISO 27020 Second edition 2019-06 Dentistry—Brackets and tubes for use in orthodontics

Withdrawn and replaced with newer version.

4-221

4-314

ISO 7494-2 Third edition 2022-07 Dentistry—Stationary dental units and dental patient chairs—Part 2: Air, water, suction and wastewater systems

Withdrawn and replaced with newer version.

4-224

4-315

ISO 24234 Third edition 2021-08 Dentistry—Dental Amalgam

Withdrawn and replaced with newer version.

4-238

4-316

ISO 20127 Second edition 2020-08 Dentistry—Physical properties of powered toothbrushes

Withdrawn and replaced with newer version.

4-244

4-317

ISO 8325 Third edition 2023-03 Dentistry—Test methods for rotary instruments

Withdrawn and replaced with newer version.

4-246

4-318

ISO 20749 Second edition 2023-06 Dentistry—Pre-capsulated dental amalgam

Withdrawn and replaced with newer version.

4-257

4-319

ISO 17730 Second edition 2020-09 Dentistry—Fluoride varnishes

Withdrawn and replaced with newer version.

4-280

ANSI/ADA Standard No. 117-2018 Fluoride varnishes

Withdrawn with transition. See 4-319.

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

No new entries at this time.

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

No new entries at this time.

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

6-338

6-497

ASTM D7866-23 Standard Specification for Radiation Attenuating Protective Gloves

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-235

7-318

CLSI EP25 2nd Edition Evaluation of Stability of

In Vitro

Medical Laboratory Test Reagents

Withdrawn and replaced with newer version.

7-304

7-319

CLSI M23 6th Edition Development of

In Vitro

Susceptibility Test Methods, Breakpoints, and Quality Control Parameters

Withdrawn and replaced with newer version.

I. Materials

8-171

8-605

ASTM F1609-23 Standard Specification for Calcium Phosphate Coatings for Implantable Materials

Withdrawn and replaced with newer version.

8-412

8-606

ASTM F2537-23 Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion

Withdrawn and replaced with newer version.

8-437

8-607

ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

Withdrawn and replaced with newer version.

8-451

8-608

ASTM F2214-2023 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)

Withdrawn and replaced with newer version.

8-475

8-609

ASTM F2026-23 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-483

8-610

ASTM F601-23 Standard Practice for Fluorescent Penetrant Inspection of Metallic 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

No new entries at this time.

N. Orthopedic

11-83

ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and thermal exposure

Transferred. See 4-320.

11-276

11-402

ASTM F1798-21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Withdrawn and replaced with newer version.

11-281

ASTM F1672-14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis

Withdrawn with transition. See 11-400.

11-299

ASTM F2068-15 Standard Specification for Femoral Prostheses—Metallic Implants

Withdrawn with transition. See 11-401.

11-301

ASTM F2091-15 Standard Specification for Acetabular Prostheses

Withdrawn with transition. See 11-401.

11-303

11-403

ASTM F3047M-23 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

Withdrawn and replaced with newer version.

11-321

11-404

ASTM F2887-23 Standard Specification for Total Elbow Prostheses

Withdrawn and replaced with newer version.

11-334

11-405

ASTM F1829-23 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

Withdrawn and replaced with newer version.

11-335

11-406

ASTM F3141-23 Standard Guide for Total Knee Replacement Loading Profiles

Withdrawn and replaced with newer version.

11-341

11-407

ASTM F3140-23 Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

Withdrawn and replaced with newer version.

11-377

ASTM F2083-21 Standard Specification for Knee Replacement Prosthesis

Withdrawn with transition. See 11-400.

O. Physical Medicine

No new entries at this time.

P. Radiology

12-348

IEC 60601-2-54 Edition 2.0 2022-09 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Extent of recognition.

12-349

12-352

NEMA PS 3.1-3.20 2023e Digital Imaging and Communications in Medicine (DICOM) set

Withdrawn and replaced with newer version.

Q. Software/Informatics

No new entries at this time.

R. Sterility

14-141

14-589

ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments—Part 4: Design, construction and start-up

Withdrawn and replaced with newer version.

14-379

14-590

ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments—Part 8: Assessment of air cleanliness by chemical concentration (ACC)

Withdrawn and replaced with newer version.

14-390

14-591

ISO 14644-10 Second edition 2022-05 Cleanrooms and associated controlled environments—Part 10: Assessment of surface cleanliness for chemical contamination

Withdrawn and replaced with newer version.

14-427

14-592

ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products—Part 1: General requirements

Withdrawn and replaced with newer version.

14-516

14-593

ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

Withdrawn and replaced with newer version.

14-530

14-594

ISO 11607-1 Second edition 2019-02 [Including ADM1:2023] Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]

Withdrawn and replaced with newer version.

14-531

14-595

ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)]

Withdrawn and replaced with newer version.

14-573

14-596

ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials

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: 061. 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

1-166

Gas mixers for medical use—Stand-alone gas mixers.

ISO 11195 Second edition 2018-01.

B. Biocompatibility

No new entries at this time.

C. Cardiovascular

3-190

Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2

ISO/PAS 7020 First edition 2023-05.

D. Dental/ENT

4-320

Surgical and dental and instruments—Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 13402 First edition 1995-08.

4-321

Dentistry—Intraoral camera

ISO 23450 First edition 2021-03.

4-322

Dentistry—Machinable ceramic blanks

ISO 18675 First edition 2022-05.

4-323

Dentistry—Polymer-based composite machinable blanks

ISO 5139 First edition 2023-05.

4-324

Dentistry—Polymer-based luting materials containing adhesive components

ISO/TS 16506 First edition 2018-03.

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

7-320

Validation of Assays Performed by Flow Cytometry

CLSI H62 1st Edition.

I. Materials

No new entries at this time.

J. Nanotechnology

18-24

Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles

ASTM E2524-22.

K. Neurology

No new entries at this time.

L. OB-Gyn/G/Urology

9-150

Copper-bearing contraceptive intrauterine devices—Requirements and tests

ISO 7439 Fourth edition 2023-04.

M. Ophthalmic

No new entries at this time.

N. OrthopedicX

11-400

Non-active surgical implants—Joint replacement implants—Specific requirements for knee-joint replacement implants

ISO 21536 Third edition 2023-07.

11-401

Non-active surgical implants—Joint replacement implants—Specific requirements for hip-joint replacement implants

ISO 21535 Third edition 2023-07.

11-408

Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

ASTM F2777-23.

11-409

Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components

ASTM F3495-23.

O. Physical Medicine

No new entries at this time.

P. Radiology

12-353

American National Standard for Safe Use of Lasers

ANSI Z136.1-2022.

Q. Software/Informatics

13-129

Software and systems engineering—Software testing—Part 1: General concepts

ISO/IEC/IEEE 29119-1 Second edition 2022-01.

13-130

Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging

ANSI/AAMI 2700-2-1:2022.

13-131

Standard for medical device security—Security risk management for device manufacturers

ANSI/AAMI SW96:2023.

R. Sterility

14-597

Water Quality for Processing Medical Devices

ANSI/AAMI ST108:2023.

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: February 26, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2024-04376 Filed 2-29-24; 8:45 am]

BILLING CODE 4164-01-P