Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060

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: 060

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: 060” (Recognition List Number: 060), 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 7, 2023.

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: 060.” 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: 060.

• 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: 060 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: 060 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: 060” to Jianchao Zeng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. 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:

Jianchao Zeng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580,

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: 060

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: 060” 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: 060.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement

recognition

No.

Title of standard

1

Change

A. Anesthesiology

1-127

1-161

ISO 16628 Second edition 2022-06 Anaesthetic and respiratory equipment—Tracheobronchial tubes

Withdrawn and replaced with newer version.

B. Biocompatibility

2-213

2-299

ASTM F1904-23 Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo

Withdrawn and replaced with newer version.

2-222

2-300

ISO 10993-2 Third edition 2022-11 Biological evaluation of medical devices—Part 2: Animal welfare requirements

Withdrawn and replaced with newer version.

2-227

2-301

ASTM F1983-23 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

Withdrawn and replaced with newer version.

C. Cardiovascular

3-87

3-184

ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses

Withdrawn and replaced with newer version.

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

4-86

ANSI/ADA Standard No. 38-2000 (R2015) Metal-Ceramic Dental Restorative Systems

Withdrawn.

4-139

ANSI/ADA Standard No. 48-2004 (R2015) Visible Light Curing Units

Withdrawn.

4-181

4-298

ISO 4049 Fifth edition 2019-05 Dentistry—Polymer-based restorative materials

Withdrawn and replaced with newer version.

4-198

4-299

ISO 3107 Fifth edition 2022-09 Dentistry—Zinc oxide-eugenol cements and non-eugenol zinc oxide cements

Withdrawn and replaced with newer version.

4-227

4-300

ISO 22674 Third edition 2022-08 Dentistry—Metallic materials for fixed and removable restorations and appliances

Withdrawn and replaced with newer version.

4-231

ISO/TS 11405 Third edition 2015-02-01 Dentistry—Testing of adhesion to tooth structure

Withdrawn.

4-240

4-301

ISO 21563 Second edition 2021-08 Dentistry—Hydrocolloid impression materials

Withdrawn and replaced with newer version.

4-248

4-302

ISO 10477 Fourth edition 2020-10 Dentistry—Polymer-based crown and veneering materials

Withdrawn and replaced with newer version.

4-249

ANSI/ADA Standard No. 19-2018 Elastometric Impression Materials

Withdrawn.

4-253

ANSI/ADA Standard No. 27-2016 Polymer-based Restorative Materials

Withdrawn. See 4-298.

4-264

4-303

ISO 9333 Third edition 2022-08 Dentistry—Brazing materials

Withdrawn and replaced with newer version.

4-267

4-304

ISO 21606 Second edition 2022-08 Dentistry—Elastomeric auxiliaries for use in orthodontics

Withdrawn and replaced with newer version.

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

No new entries at this time.

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

19-34

IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements [Including: Corrigendum 1 (2019)]

Recognition restored.

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

6-253

6-486

ISO 10535 Third Edition 2021-10 Assistive products—Hoists for the transfer of persons—Requirements and test methods

Withdrawn and replaced with newer version.

6-296

6-487

AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

Withdrawn and replaced with newer version.

6-306

6-488

ASTM F1671/F1671M-22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

Withdrawn and replaced with newer version.

6-321

6-489

IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment—Part 2-52: Particular requirements for the basic safety and essential performance of medical beds

Withdrawn and replaced with newer version.

6-357

6-490

ISO 10555-6 First edition 2015-04-15 Intravascular catheters—Sterile and single-use catheters—Part 6: Subcutaneous implanted ports [Including Amendment 1 (2019)]

Withdrawn and replaced with newer version.

6-402

6-491

ASTM F1670/F1670M-17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Withdrawn and replaced with newer version.

6-425

6-492

ASTM F2100-23 Standard Specification for Performance of Materials Used in Medical Face Masks

Withdrawn and replaced with newer version.

6-427

6-493

ASTM F2101-23 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.

6-474

6-494

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

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-152

7-315

CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance

Withdrawn and replaced with newer version.

7-244

7-316

CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening

Withdrawn and replaced with newer version.

7-308

7-317

CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing

Withdrawn and replaced with newer version.

I. Materials

8-200

8-597

ASTM F2003-02(2022) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air

Withdrawn and replaced with newer version.

8-441

8-598

ASTM F3109-22 Standard Practice for Verification of Multi-Axis Force Measuring Platforms

Withdrawn and replaced with newer version.

8-453

8-599

ASTM F1295-22 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

Withdrawn and replaced with newer version.

8-467

8-600

ASTM F1978-22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

Withdrawn and replaced with newer version.

8-506

8-601

ASTM F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

Withdrawn and replaced with newer version.

8-528

8-602

ASTM F2503-23 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Withdrawn and replaced with newer version.

8-555

8-603

ASTM F1472-23 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

Withdrawn and replaced with newer version.

J. Nanotechnology

18-15

18-23

ASTM E3025-22 Standard Guide for Tiered Approach to Detection and Characterization of Silver Nanomaterials in Textiles

Withdrawn and replaced with newer version.

K. Neurology

No new entries at this time.

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

9-67

9-145

ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Withdrawn and replaced with newer version.

9-94

9-146

ISO 8600-4 Third Edition 2023-01 Endoscopes—Medical endoscopes and endotherapy devices—Part 4: Determination of maximum width of insertion portion

Withdrawn and replaced with newer version.

9-125

9-147

ISO/CIE 11664-2 First edition 2022-08 Colorimetry—Part 2: CIE standard illuminants

Withdrawn and replaced with newer version.

9-128

9-148

ISO/CIE 11664-6 Second edition 2022-08 Colorimetry—Part 6: CIEDE2000 Colour-difference formula

Withdrawn and replaced with newer version.

9-143

ISO 20696 First edition 2018-06 Corrected version 2019-12 Sterile urethral catheters for single use

Extent of recognition.

M. Ophthalmic

No new entries at this time.

N. Orthopedic

11-294

11-399

ASTM F1357-23 Standard Specification for Articulating Total Wrist Implants

Withdrawn and replaced with newer version.

O. Physical Medicine

16-165

16-234

ISO 7176-14 Third Edition 2022 Wheelchairs—Part 14 Power and control systems for electrically powered wheelchairs and scooters—Requirements and test methods

Withdrawn and replaced with newer version.

16-194

16-235

ISO 7176-25 Second Edition 2022 Wheelchairs—Part 25: Lead-acid batteries and chargers for powered wheelchairs—Requirements and test methods

Withdrawn and replaced with newer version.

16-201

16-236

ISO 7176-19 Third Edition 2022 Wheelchairs—Part 19: Wheeled mobility devices for use as seats in motor vehicles

Withdrawn and replaced with newer version.

P. Radiology

12-6

12-350

IEC 60806 Edition 2.0 2022-11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis

Withdrawn and replaced with newer version.

12-347

IEC 60601-2-33 Edition 4.0 2022-08 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Transition period extended.

12-329

12-351

IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Withdrawn and replaced with newer version.

Q. Software/Informatics

No new entries at this time.

R. Sterility

14-169

14-584

ASTM F2391-22 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

Withdrawn and replaced with newer version.

14-456

14-585

ISO/TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

Withdrawn and replaced with newer version.

14-575

ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Transition period extended.

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: 060. 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

3-185

Active implantable medical devices—Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

ANSI/AAMI PC76:2021.

3-186

Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers

ISO 14708-2 Third edition 2019-09.

3-187

Implants for surgery—Active implantable medical devices—Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

ISO 14708-6 Second edition 2019-09.

3-188

Non-invasive sphygmomanometers—Part 3: Clinical investigation of continuous automated measurement type

ISO 81060-3 First edition 2022-12.

D. Dental/ENT

4-305

Dentistry—Central suction source equipment

ISO 10637 Second edition 2018-05.

4-306

Dentistry—Compressed air source equipment

ISO 22052 First edition 2020-06.

4-307

Dentistry—General requirements for instruments and related accessories used in dental implant placement and treatment

ISO 13504 First edition 2012-07.

4-308

Implants for surgery—Active implantable medical devices—Part 7: Particular requirements for cochlear and auditory brainstem implant systems

ISO 14708-7 Second edition 2019-12 (Corrected version 2020-05).

E. General I (QS/RM)

No new entries at this time.

F. General II (ES/EMC)

19-49

Medical electrical equipment—Part 1: General requirements for basic safety and essential performance

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION.

G. GH/GPS

6-495

Catheter systems for neuraxial application—Sterile and single-use catheters and accessories

ISO 20698 First Edition 2018-07.

6-496

Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

ASTM F739-20.

H. IVD

No new entries at this time.

I. Materials

8-604

Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)

ASTM F2257-22.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. OB-Gyn/G/Urology

9-149

Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC 60601-2-39 Edition 3.0 2018-04.

M. Ophthalmic

No new entries at this time.

N. Orthopedic

No new entries at this time.

O. Physical Medicine

No new entries at this time.

P. Radiology

No new entries at this time.

Q. Software/Informatics

No new entries at this time.

R. Sterility

14-586

Sterilization of health care products—Low temperature vaporized hydrogen peroxide—Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 22441 First edition 2022-08.

14-587

Guidance on transferring health care products between radiation sterilization sources

AAMI TIR104:2022.

14-588

Compatibility of materials subjected to sterilization

AAMI TIR17:2017/(R)2020.

S. Tissue Engineering

No new entries at this time.

1

All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

Such standards are those that FDA has recognized by notice published in the

Federal Register

or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the

Federal Register

). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the

Federal Register

once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to

CDRHStandardsStaff@fda.hhs.gov.

To be considered, such recommendations should contain, at a minimum, the information available at

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

Dated: August 2, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-16770 Filed 8-4-23; 8:45 am]

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