Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055

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: 055

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: 055” (Recognition List Number: 055), 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 29, 2021.

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: http://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: 055.” 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: 055.

• 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: 055 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: 055 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: 055” 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: 055

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: 055” 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: 055.

Table 1—Modifications to the List of Recognized Standards

Old

recognition

No.

Replacement

recognition

No.

Title of standard

1

Change

A. Anesthesiology

1-79

1-147

ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during anaesthesia—Colours, design and performance

Withdrawn and replaced with newer version.

1-102

1-148

ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment—Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

Withdrawn and replaced with newer version.

1-123

1-149

ISO 7376 Third edition 2020-08 Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubation

Withdrawn and replaced with newer version.

1-125

1-150

ISO 8836 Fifth edition 2019-12 Suction catheters for use in the respiratory tract

Withdrawn and replaced with newer version.

1-146

ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Transition period extended.

B. Biocompatibility

2-119

2-277

ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

Withdrawn and replaced with newer version.

2-122

2-278

ASTM F719-20 ε1 Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

Withdrawn and replaced with newer version.

2-124

2-279

ASTM F750-20 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

Withdrawn and replaced with newer version.

2-133

2-280

ASTM F1408-20a Standard Practice for Subcutaneous Screening Test for Implant Materials

Withdrawn and replaced with newer version.

2-167

2-281

ISO 10993-19 Second edition 2020-03 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

Withdrawn and replaced with newer version.

2-205

2-282

ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects—Good clinical practice

Withdrawn and replaced with newer version.

2-214

2-283

ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices

Withdrawn and replaced with newer version.

2-269

2-284

USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-270

2-285

USP 43-NF38:2020 <87> Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version.

2-271

2-286

USP 43-NF38:2020 <88> Biological Reactivity Tests, In Vivo

Withdrawn and replaced with newer version.

2-272

2-287

USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version.

C. Cardiovascular

No new entries at this time.

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

4-92

4-264

ANSI/ADA Standard No. 88—2019 Dental Brazing Alloys

Withdrawn and replaced with newer version.

4-243

ISO 10271 First edition 2001-06 Dental metallic materials—Corrosion test methods

Withdrawn.

4-245

4-265

ISO 10271 Third edition 2020-08 Dentistry—Corrosion test methods for metallic materials

Withdrawn and replaced with newer version.

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

5-76

5-131

IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Withdrawn and replaced with newer version.

5-89

5-132

IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability

Withdrawn and replaced with newer version.

5-115

5-133

ISO 80369-7 Second edition 2021 Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications

Withdrawn and replaced with newer version.

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

19-8

19-36

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests

Withdrawn and replaced with newer version.

19-9

19-37

IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-10: General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Withdrawn and replaced with newer version.

19-14

19-38

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Withdrawn and replaced with newer version.

19-15

19-39

IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Withdrawn and replaced with newer version.

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

6-11

ISO 594-1 First edition 1986-06-15 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment—Part 1: General requirements

Withdrawn. See 5-133.

6-129

ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment—Part 2: Lock fittings

Withdrawn. See 5-133.

6-180

6-448

ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

Withdrawn and replaced with newer version.

6-339

6-449

ASTM F1169-19 Standard Consumer Safety Specification for Full-Size Baby Cribs

Withdrawn and replaced with newer version.

6-340

ASTM F2710-13 Standard Consumer Safety Performance Specification for Commercial Cribs

Withdrawn.

6-387

6-450

IEC 60601-2-50 Ed. 3.0 2020-09 Medical electrical equipment—Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Withdrawn and replaced with newer version.

6-428

6-451

USP 43-NF38:2020 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-429

6-452

USP 43-NF38:2020 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-430

6-453

USP 43-NF38:2020 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-431

6-454

USP 43-NF38:2020 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-432

6-455

USP 43-NF38:2020 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-433

6-456

USP 43-NF38:2020 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-434

6-457

USP 43-NF38:2020 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-435

6-458

USP 43-NF38:2020 Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

6-436

6-459

USP 43-NF38:2020 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-101

CLSI H51-A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline

Withdrawn.

7-112

7-299

CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and Anticoagulation Monitoring

Withdrawn and replaced with newer version.

7-131

CLSI I/LA18-A2 (Replaces I/LA18-A) Specifications for Immunological Testing for Infectious Diseases; Approved Guideline—Second Edition

Withdrawn.

7-135

CLSI H44-A2 (Replaces H44-A) Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline—Second Edition

Withdrawn.

7-142

CLSI GP43-A4 (Formerly H11-A4) Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition

Withdrawn.

7-146

CLSI M06-A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—Second Edition

Withdrawn.

7-164

CLSI GP28-A (Replaces GP28-P) Microwave Device Use in the Histology Laboratory; Approved Guideline

Withdrawn.

7-173

CLSI C44-A (Replaces C44-P) Harmonization of Glycohemoglobin Measurements; Approved Guideline

Withdrawn.

7-191

7-300

CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods

Withdrawn and replaced with newer version.

7-203

7-301

CLSI GP42 7th Edition Collection of Capillary Blood Specimens

Withdrawn and replaced with newer version.

7-211

7-302

CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis

Withdrawn and replaced with newer version.

7-217

7-303

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

Withdrawn and replaced with newer version.

7-261

7-304

CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters

Withdrawn and replaced with newer version.

I. Materials

8-217

8-537

ASTM F620-20 Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition

Withdrawn and replaced with newer version.

8-223

8-538

ASTM F2759-19 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices

Withdrawn and replaced with newer version.

8-338

8-539

ASTM F139-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

Withdrawn and replaced with newer version.

8-339

8-540

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

Withdrawn and replaced with newer version.

8-342

8-541

ASTM F1537-20 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

Withdrawn and replaced with newer version.

8-348

8-542

ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

Withdrawn and replaced with newer version.

8-361

8-543

ASTM F755-19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

Withdrawn and replaced with newer version.

8-395

8-544

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

Withdrawn and replaced with newer version.

8-416

8-545

ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

Withdrawn and replaced with newer version.

8-417

8-546

ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

Withdrawn and replaced with newer version.

8-421

8-547

ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants

Withdrawn and replaced with newer version.

8-438

8-548

ISO/ASTM 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2

Withdrawn and replaced with newer version.

8-530

8-549

ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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)

9-40

9-130

ISO 8600-6: Second Edition 2020-09 Endoscopes—Medical endoscopes and endotherapy devices—Part 6: Vocabulary

Withdrawn and replaced with newer version.

M. Ophthalmic

10-48

10-119

ISO 11979-5 Third edition 2020-09 Ophthalmic implants—Intraocular Lenses—Part 5: Biocompatibility

Withdrawn and replaced with newer version.

10-63

10-120

ISO/TR 22979 Second Edition 2017-05 Ophthalmic implants—Intraocular Lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

Withdrawn and replaced with newer version.

N. Orthopedic

11-191

11-370

ISO 14879-1 Second edition 2020-07 Implants for surgery—Total knee-joint prostheses—Part 1: Determination of endurance properties of knee tibial trays

Withdrawn and replaced with newer version.

11-267

11-371

ASTM F2009-20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses

Withdrawn and replaced with newer version.

11-279

11-372

ASTM F2996-20 Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems

Withdrawn and replaced with newer version.

11-282

11-373

ASTM F1223-20 Standard Test Method for Determination of Total Knee Replacement Constraint

Withdrawn and replaced with newer version.

11-313

11-374

ISO 7207-2 Second edition 2011-07-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]

Withdrawn and replaced with newer version.

11-330

ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Extent of recognition.

11-332

11-375

ASTM F2193-20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Withdrawn and replaced with newer version.

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

14-314

14-550

ANSI/AAMI ST67:2019 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”

Withdrawn and replaced with newer version.

14-361

14-551

ISO 14160 Third edition 2020-09 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

Withdrawn and replaced with newer version.

14-411

14-552

ISO/ASTM 51818 Fourth edition 2020-06 Practice for dosimetry in an electron beam facility for radiation processing at energies between 80 and 300 keV

Withdrawn and replaced with newer version.

14-498

14-553

ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Withdrawn and replaced with newer version.

14-519

14-554

ASTM F17-20 Standard Terminology Relating to Primary Barrier Packaging

Withdrawn and replaced with newer version.

14-534

14-555

USP 43-NF38:2020 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests

Withdrawn and replaced with newer version.

14-535

14-556

USP 43-NF38:2020 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-536

14-557

USP 43-NF38:2020 <55> Biological Indicators—Resistance Performance Tests

Withdrawn and replaced with newer version.

14-537

14-558

USP 43-NF38:2020 <1229.5> Biological Indicators for Sterilization

Withdrawn and replaced with newer version.

14-546

14-559

USP 43-NF38:2020 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-547

14-560

USP 43-NF38:2020 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-548

14-561

USP 43-NF38:2020 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

S. Tissue Engineering

15-35

ASTM F2900-11 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine

Withdrawn.

15-36

ASTM F2383-11 Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)

Withdrawn.

15-38

ASTM F2883-11 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications

Withdrawn.

15-45

15-64

ISO 22442-1 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management

Withdrawn and replaced with newer version.

15-46

15-65

ISO 22442-2 Third edition 2020-09 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling

Withdrawn and replaced with newer version.

1

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

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 055. 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

2-288

Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys

ISO 10993-15 Second edition 2019-11.

C. Cardiovascular

3-169

Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

IEC Edition 3.1 2018-02 CONSOLIDATED VERSION.

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

4-266

Dentistry—Orthodontic anchor screws

ISO 19023 First edition 2018-02.

4-267

Dentistry—Elastomeric auxiliaries for use in orthodontics

ISO 21606 First edition 2007-06.

4-268

Dentistry—Wires for use in orthodontics [Including AMENDMENT 1 (2020)]

ISO 15841 Second edition 2014-08.

4-269

Dentistry—Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]

ISO 3964 Third edition 11-2016.

4-270

CAD/CAM Abutments in Dentistry

ADA Technical Report No. 146-2018.

4-271

Dental Cartridge Syringes

ANSI/ADA Standard No. 34-2013.

4-272

Root Canal Barbed Broaches and Rasps.

ANSI/ADA Standard No. 63-2013.

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)

No new entries at this time.

H. In Vitro Diagnostics (IVD)

7-305

In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.

ISO 17511 Second edition 2020-04.

I. Materials

8-550

Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants

ASTM F2181-20.

8-551

Standard Practice for Digital Radiography of Cast Metallic Implants

ASTM F2895-20.

8-552

Guide for Additive manufacturing—Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing New publication

ASTM F3434-20.

8-553

Additive manufacturing—Material extrusion-based additive manufacturing of plastic materials—Part 1: Feedstock materials

ISO/ASTM 52903-1 First edition 2020-04.

8-554

Additive manufacturing—Design—Functionally graded additive manufacturing

ISO/ASTM TR 52912 First edition 2020-09.

J. Nanotechnology

18-17

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

ISO 21363 First edition 2020-06.

18-18

Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media Using Dynamic Light Scattering

ASTM E3247-20.

K. Neurology

17-17

Standard Specification for Neurosurgical Head Holder Devices

ASTM F3395/F3395M-19.

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

No new entries at this time.

M. Ophthalmic

10-121

Ophthalmic implants—Ocular endotamponades

ISO 16672 Third edition 2020-06.

N. Orthopedic

No new entries at this time.

O. Physical Medicine

16-230

American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs

ANSI/RESNA WC-2:2019 Section 25.

P. Radiology

No new entries at this time.

Q. Software/Informatics

13-116

Common Vulnerability Scoring System version 3.0

FIRST CVSS v3.0.

R. Sterility

No new entries at this time.

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

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 23, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

[FR Doc. 2021-08992 Filed 4-28-21; 8:45 am]

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