Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 057

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: 057

AGENCY:

Food and Drug Administration, Health and Human Services (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: 057” (Recognition List Number: 057), 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 April 22, 2022.

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: 057.” 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: 057.

• 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: 057 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: 057 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: 057” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. 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:

Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287,

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 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 hypertext markup language (HTML) and portable document format (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: 057

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: 057” 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: 057.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement

recognition

No.

Title of standard

1

Change

A. Anesthesiology

No new entries at this time.

B. Biocompatibility

2-275

ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]

Title change.

2-284

2-292

USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-285

2-293

USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version.

2-286

2-294

USP-NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo

Withdrawn and replaced with newer version.

2-287

2-295

USP-NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test).

Withdrawn and replaced with newer version.

C. Cardiovascular

3-88

3-171

ASTM F2514-21 Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

Withdrawn and replaced with newer version.

3-99

3-172

AAMI TIR42:2021 Evaluation of particulate associated with vascular medical devices

Withdrawn and replaced with newer version.

3-133

3-173

ISO 5840-3 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

Withdrawn and replaced with newer version.

3-145

3-174

ISO 5840-1 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements

Withdrawn and replaced with newer version.

3-147

3-175

ISO 5840-2 Second edition 2021-01 Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes

Withdrawn and replaced with newer version.

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

4-89

ANSI/ADA Standard No. 53—2008 (R2013) Polymer-Based Crown and Bridge Materials

Withdrawn.

4-282

4-284

ISO 10873 Second edition 2021-07 Dentistry—Denture adhesives

Withdrawn and replaced with newer version.

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

5-117

5-134

ISO 15223-1 Fourth edition 2021-07 Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 1: General requirements

Withdrawn and replaced with newer version.

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

19-34

19-41

ANSI/UL 61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements

Withdrawn and replaced with newer version.

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

6-365

6-464

ISO 11040-4 Third edition 2015-04-01 Prefilled syringes—Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]

Withdrawn and replaced with newer version.

6-451

6-465

USP-NF M76090_03_01 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-452

6-466

USP-NF M76070_03_01 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-453

6-467

USP-NF M80200_04_01 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-454

6-468

USP-NF M99670_02_01 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-455

6-469

USP-NF M99650_02_01 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-456

6-470

USP-NF M99660_03_01 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-457

6-471

USP-NF M88880_05_01 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-458

6-472

USP-NF M36660_04_01 Heparin Lock Flush Solution.

Withdrawn and replaced with newer version.

6-459

6-473

USP-NF M80190_04_01 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

No new entries at this time.

I. Materials

8-103

8-563

ASTM F1801-20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

Withdrawn and replaced with newer version.

8-121

8-564

ASTM F2005-21 Standard Terminology for Nickel-Titanium Shape Memory Alloys

Withdrawn and replaced with newer version.

8-193

8-565

ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber Cast Helix and Direction of Helix of Coiled Wire

Withdrawn and replaced with newer version.

8-346

8-566

ASTM F1813-21 Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120)

Withdrawn and replaced with newer version.

8-353

8-567

ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-355

8-568

ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)

Withdrawn and replaced with newer version.

8-385

8-569

ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

Withdrawn and replaced with newer version.

8-398

8-570

ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants

Withdrawn and replaced with newer version.

8-422

8-571

ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

Withdrawn and replaced with newer version.

8-423

8-572

ASTM F2565-21 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-424

8-573

ASTM F2695-12(2020) Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-425

8-574

ASTM F2820-12(2021)e1 Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-443

8-575

ASTM F3160-21 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants

Withdrawn and replaced with newer version.

8-450

8-576

ASTM F451-21 Standard Specification for Acrylic Bone Cement

Withdrawn and replaced with newer version.

8-456

8-577

ISO 13179-1 Second Edition 2021-09 Implants for surgery—Coatings on metallic surgical implants—Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders

Withdrawn and replaced with newer version. Title change.

8-460

8-578

ASTM F2848-21 Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns

Withdrawn and replaced with newer version.

8-515

8-579

ISO 13779-3 Second Edition 2018-12 Implants for surgery—Hydroxyapatite—Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]

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

10-73

10-127

ANSI Z80.21-2020 American National Standard for Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts

Withdrawn and replaced with newer version.

10-87

10-128

ASTM D882-18 Standard Test Method for Tensile Properties of Thin Plastic Sheeting

Withdrawn and replaced with newer version.

10-88

10-129

ASTM D790-17 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

Withdrawn and replaced with newer version.

10-102

10-130

ANSI Z80.36-2021 American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments

Withdrawn and replaced with newer version.

N. Orthopedic

11-239

11-385

ASTM F2345-21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads

Withdrawn and replaced with newer version.

11-266

11-386

ASTM F2665-21 Standard Specification for Total Ankle Replacement Prosthesis

Withdrawn and replaced with newer version.

11-305

11-387

ASTM F1781-21 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

Withdrawn and replaced with newer version.

11-345

11-388

ASTM F1717-21 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

11-359

11-389

ISO 7206-10 Second edition 2018-08 Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]

Withdrawn and replaced with newer version.

O. Physical Medicine

No new entries at this time.

P. Radiology

12-299

12-341

IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION Medical electrical equipment—Medical image display systems—Part 1: Evaluation methods

Withdrawn and replaced with newer version.

12-300

12-342

NEMA DICOM PS 3.1—3.20 2021e Digital Imaging and Communications in Medicine (DICOM) Set

Withdrawn and replaced with newer version.

Q. Software/Informatics

13-46

ASTM F2761-09 (2013) Medical Devices and Medical Systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model

Withdrawn. See 13-120.

R. Sterility

14-424

14-563

ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products—Part 6: Isolator systems

Withdrawn and replaced with newer version.

14-555

14-564

USP-NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests

Withdrawn and replaced with newer version.

14-556

14-565

USP-NF M98802_01_01 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-557

14-566

USP-NF M98795_02_01 <55> Biological Indicators—Resistance Performance Tests

Withdrawn and replaced with newer version.

14-558

14-567

USP-NF M7414_01_01 <1229.5> Biological Indicators for Sterilization

Withdrawn and replaced with newer version.

14-559

14-568

USP-NF M98800_01_01 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-560

14-569

USP-NF M98810_01_01 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-561

14-570

USP-NF M98830_02_01 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

S. Tissue Engineering

15-29

ASTM F2259-10 (Reapproved 2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy

Withdrawn.

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: 057. 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

3-176

Cardiovascular implants and artificial organs—Cannulae for extracorporeal circulation

ISO 18193 First edition 2021-08.

3-177

Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

ASTM F2606-08 (Reapproved 2021).

3-178

Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents

ASTM F3067-14 (Reapproved 2021).

3-179

Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

ASTM F3172-15 (Reapproved 2021).

3-180

Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance

ASTM F3505-21.

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

4-285

Dental Abrasive Powders

ANSI/ADA Standard No. 37—1986 (R2020).

4-286

Dental Impression Trays

ANSI/ADA Standard No. 87—1995 (R2014).

4-287

Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products—Oral Rinses)

ANSI/ADA Standard No. 116—2020.

4-288

Dentistry—Mixing machines for dental amalgam

ISO 7488 Second edition 2018-04.

4-289

Dentistry—Intraoral spatulas

ISO 18556 First edition 2016-04.

4-290

Dentistry—Integrated dental floss and handles

ISO 28158 Second edition 2018-09.

4-291

Dentistry—Products for external tooth bleaching

ISO 28399 First edition 2011-01.

4-292

Dentistry—Screening method for erosion potential of oral rinses on dental hard tissues

ISO 28888 First edition 2013-10.

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

No new entries at this time.

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

19-42

Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 1: General requirements

IEC 61326-1 Edition 3.0 2020-10.

19-43

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

IEC 61326-2-6 Edition 3.0 2020-10.

19-44

American National Standard—Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems

ANSI/IEEE C63.24-2021.

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

6-474

Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

ASTM F3352-19.

H. In Vitro Diagnostics (IVD)

7-309

Radiological protection—Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry

ISO 17099 First edition 2014-11-15.

7-310

Radiological protection—Performance criteria for service laboratories performing biological dosimetry by cytogenetics

ISO 19238 Second edition 2014-02-01.

7-311

A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests

CLSI EP39, 1st Edition

I. Materials

8-580

Eyewear display—Part 20-10: Fundamental measurement methods—Optical properties

IEC 63145-20-10 Edition 1.0 2019-08.

8-581

Eyewear display—Part 20-20: Fundamental measurement methods—Image quality

IEC 63145-20-20 Edition 1.0 2019-09.

8-582

Eyewear display—Part 22-10: Specific measurement methods for AR type—Optical properties

IEC 63145-22-10 Edition 1.0 2020-01.

J. Nanotechnology

18-19

Nanotechnologies—Measurements of particle size and shape distributions by scanning electron microscopy

ISO 19749 First edition 2021-07.

18-20

Standard Guide for Visualization and Identification of Nanomaterials in Biological and Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/HSI) Analysis

ASTM E3275-21.

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

11-390

Implants for surgery—Pre-clinical mechanical assessment of spinal implants and particular requirements—Part 2: Spinal intervertebral body fusion devices

ISO 23089-2 First edition 2021-05.

11-391

Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops

ASTM F2722-21.

11-392

Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

ASTM F2723-21.

11-393

Standard Test Method for Evaluating Mobile Bearing Knee Dislocation

ASTM F2724-21.

O. Physical Medicine

16-232

Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

IEC 80601-2-78 Edition 1.0 2019-07.

P. Radiology

No new entries at this time.

Q. Software/Informatics

13-120

Medical Devices and Medical Systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model

ANSI/AAMI 2700-1:2019.

R. Sterility

14-571

Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation time for a biological indicator

ISO 11138-8 First edition 2021-07.

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: April 18, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2022-08571 Filed 4-21-22; 8:45 am]

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