Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 059

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: 059

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: 059” (Recognition List Number: 059), 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 2, 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: 059.” 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: 059.

• 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: 059 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: 059 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: 059” 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: 059

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: 059” 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: 059.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement recognition No.

Title of standard

1

Change

A. Anesthesiology

1-67

1-153

NFPA 99:2021 Health Care Facilities Code

Withdrawn and replaced with newer version.

1-78

1-154

ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy

Withdrawn and replaced with newer version.

1-132

1-155

ISO 10079-2 Fourth edition 2022-03 Medical suction equipment—Part 2: Manually powered suction equipment

Withdrawn and replaced with newer version.

1-133

1-156

ISO 10079-3 Fourth edition 2022-03 Medical suction equipment—Part 3: Suction equipment powered from a vacuum or positive pressure gas source

Withdrawn and replaced with newer version.

1-142

1-157

ISO 10079-1 Fourth edition 2022-03 Medical suction equipment—Part 1: Electrically powered suction equipment

Withdrawn and replaced with newer version.

B. Biocompatibility

2-93

2-297

ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials

Withdrawn and replaced with newer version.

2-276

2-298

ISO 10993-18 Second edition 2020-01 Amendment 1:2022-05 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]

Withdrawn and replaced with newer version, including amendment.

2-289

ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials

Transition period extended.

2-296

ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices—Part 10: Tests for skin sensitization

Transition period extended.

C. Cardiovascular

No new entries at this time.

D. Dental/Ear, Nose, and Throat

4-234

4-294

ANSI/ADA Standard No. 139-2020 Dental Base Polymers

Withdrawn and replaced with newer version.

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

15-135

5-135

ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices—Information to be supplied by the manufacturer

New recognition number.

5-99

5-136

ASTM D4332-22 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

Withdrawn and replaced with newer version.

5-104

5-137

IEC TR 60878 Edition 4.0 2022-11 Graphical symbols for electrical equipment in medical practice

Withdrawn and replaced with newer version.

5-118

5-138

AAMI TIR66:2017/(R)2020 Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

New recognition number.

5-119

5-139

ISO 18250-3 First edition 2018-06 Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 3: Enteral application

New recognition number.

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

19-29

19-48

IEEE ANSI/USEMCSC C63.27 American National Standard for Evaluation of Wireless Coexistence

Withdrawn and replaced with newer version.

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

6-390

IEC 80601-2-35 Edition 2.1 2016-04 CONSOLIDATED VERSION Medical electrical equipment-Part—2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including Amendment 1 (2016)]

Withdrawn. See 6-483.

6-460

6-484

ASTM F3502-22a Standard Specification for Barrier Face Coverings

Extent of recognition. Withdrawn and replaced with a newer version.

H. In Vitro Diagnostics (IVD)

7-291

7-313

CLSI EP27 2nd Edition Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures

Extent of recognition. Withdrawn and replaced with newer version.

7-303

CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of Yeast

Withdrawn. See 7-314.

I. Materials

8-61

8-594

ISO 5832-6 Third Edition 2022-03 Implants for surgery—Metallic materials—Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy

Withdrawn and replaced with newer version.

8-123

8-595

ISO 5832-5 Fourth Edition 2022-03 Implants for surgery—Metallic materials—Part 5: Wrought cobalt-chromium-tungsten-nickel

Withdrawn and replaced with newer version.

8-559

8-596

ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

Withdrawn and replaced with newer version.

J. Nanotechnology

18-4

18-21

ISO/TS 80004-6 Second edition 2021-03 Nanotechnologies—Vocabulary—Part 6: Nano-object characterization

Withdrawn and replaced with newer version.

18-12

18-22

ISO 17200 First edition 2020-09 Nanotechnology—Nanoparticles in powder form—Characteristics and measurements

Withdrawn and replaced with newer version.

K. Neurology

No new entries at this time.

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

9-89

ISO 8638 Third edition 2010-07-01 Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters

Withdrawn. See 9-140.

M. Ophthalmic

10-37

10-132

ISO 10942 Third edition 2022-01 Ophthalmic instruments—Direct ophthalmoscopes

Extent of recognition. Withdrawn and replaced with newer version.

10-91

10-133

ISO 11979-10 Second edition 2018-03 Ophthalmic implants—Intraocular lenses—Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

Withdrawn and replaced with newer version.

N. Orthopedic

11-264

11-394

ASTM F1820-22 Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices

Withdrawn and replaced with newer version.

11-306

11-395

ASTM F1814-22 Standard Guide for Evaluating Modular Hip and Knee Joint Components

Withdrawn and replaced with newer version.

11-320

11-396

ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] Implants for surgery—Partial and total hip joint prostheses—Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including Amendment 1 (2022)]

Withdrawn and replaced with newer version including amendment.

O. Physical Medicine

16-191

ISO 7176-16 Second edition 2012-12-01 Wheelchairs—Part 16: Resistance to ignition of postural support devices

Withdrawn. See 16-233.

P. Radiology

12-113

12-346

ISO 12005 Third edition 2022-05 Lasers and laser-related equipment—Test methods for laser beam parameters—Polarization

Withdrawn and replaced with newer version.

12-295

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

Extent of recognition. Withdrawn and replaced with newer version.

12-317

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. Withdrawn and replaced with newer version.

12-342

12-349

NEMA Digital Imaging and Communications in Medicine (DICOM) Set PS3.1-3.20 2022d

Withdrawn and replaced with newer version.

Q. Software/Informatics

13-109

13-121

ANSI/AAMI/UL 2800-1:2022 Standard for Medical Device Interoperability

Withdrawn and replaced with newer version. See 13-125, 13-126, 13-127.

R. Sterility

14-409

14-580

ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose [Including Amendment 1 (2022)]

Withdrawn and replaced with newer version.

14-527

14-581

ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

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: 059. 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

1-158

Medical suction equipment—Part 4: General requirements

ISO 10079-4 First edition 2021-08.

1-159

Respiratory equipment—Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

ISO 18778 Second edition 2022-06.

1-160

Medical electrical equipment—Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

ISO 80601-2-84 First edition 2020-07.

B. Biocompatibility

No new entries at this time.

C. Cardiovascular

3-183

Cardiovascular implants and extracorporeal systems—Blood/tissue contact surface modifications for extracorporeal perfusion systems

ISO 11658 First edition 2012-05-15.

D. Dental/ENT

4-295

Evaluation of biocompatibility of medical devices used in dentistry

ANSI/ADA Standard No. 41-2020.

4-296

Dentistry—Intra-oral mirrors

ISO 9873 Fourth edition 2019-03.

4-297

Dentistry—Manual toothbrushes—General requirements and test methods

ISO 20126 Third edition 2022-03.

E. General I (QS/RM)

5-140

Standard for verification and validation in computational solid mechanics

ASME V&V 10-2019.

5-141

Standard for verification and validation in computational fluid dynamics and heat transfer

ASME V&V 20-2009 (R2021).

F. General II (ES/EMC)

No new entries at this time.

G. GH/GPS

6-483

Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

IEC 60601-2-35 Edition 2.0 2020-09.

6-485

Sterile hypodermic syringes for single use—Part 4: Syringes with re-use prevention feature

ISO 7886-4 Second Edition 2018-11.

H. IVD

7-314

Performance Standards for Antifungal Susceptibility Testing of Yeasts

CLSI M27M44S, 3rd Edition.

I. Materials

No new entries at this time.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. OB-Gyn/G/Urology

9-140

Extracorporeal systems for blood purification—Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters

ISO 8637-2 First Edition 2018-07.

9-141

Extracorporeal systems for blood purification—Part 3: Plasmafilters

ISO 8637-3 First Edition 2018-07.

9-142

Standard test method for static and kinetic coefficients of friction of plastic film and sheeting

ASTM D1894-14.

9-143

Sterile urethral catheters for single use

ISO 20696 First edition 2018-06 Corrected 2019-12.

9-144

Sterile drainage catheters and accessory devices for single use

ISO 20697 First edition 2018-06 Corrected 2019-09.

M. Ophthalmic

No new entries at this time.

N. Orthopedic

11-397

Standard test method for fatigue testing of total knee femoral components under closing conditions

ASTM F3210-22e1.

11-398

Standard test methods for sacroiliac joint fusion devices

ASTM F3574-22.

O. Physical Medicine

16-233

Wheelchair seating—Part 10: Resistance to ignition of postural support devices—Requirements and test method

ISO 16840-10 Second edition 2021-06 Corrected version 2022-01.

P. Radiology

No new entries at this time.

Q. Software/Informatics

13-122

Health software and health IT systems safety, effectiveness and security—Part 5-1: Security—Activities in the product life cycle

IEC 81001-5-1 Edition 1.0 2021-12.

13-123

Manufacturer disclosure statement for medical device security

ANSI/NEMA HN 1-2019.

13-124

Guidance on the application of ISO 14971 to artificial intelligence and machine learning

AAMI CR34971:2022.

13-125

Standard for risk concerns for interoperable medical products

ANSI/AAMI/UL 2800-1-1:2022.

13-126

Standard for interoperable item development life cycle

ANSI/AAMI/UL 2800-1-2:2022.

13-127

Standard for Interoperable item integration life cycle

ANSI/AAMI/UL 2800-1-3:2022.

13-128

IEEE/UL Standard for wireless diabetes device security: Information security requirements for connected diabetes solutions

IEEE Std 2621.2-2022/UL 2621-2:2022.

R. Sterility

14-582

Sterilization of health care products—Radiation—Part 4: Guidance on process control

ISO/TS 11137-4 First edition 2020-06.

14-583

Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.

ANSI/AAMI ST98:2022.

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: July 28, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2023-16418 Filed 8-1-23; 8:45 am]

BILLING CODE 4164-01-P