Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053

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: 053

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: 053” (Recognition List Number: 053), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 30, 2020.

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: 053.” 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. 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: 053.

• 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.

An electronic copy of Recognition List Number: 053 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: 053 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: 053” 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 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 a portable document format (PDF) version of the list of FDA Recognized Consensus Standards. 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: 053

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: 053” 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: 053.

Table 1—Modifications to the List of Recognized Standards

Old recognition No.

Replacement recognition No.

Title of standard

1

Change

A. Anesthesiology

1-47

AS 4259-1995 Ancillary devices for expired air resuscitation

Withdrawn.

1-102

ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment—Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

Extent of Recognition.

B. Biocompatibility

2-259

2-269

USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-260

2-270

USP 42-NF37:2019 <87> Biological Reactivity Test, In Vitro-Elution Test

Withdrawn and replaced with newer version.

2-261

2-271

USP 42-NF37:2019 <88> Biological Reactivity Tests, In Vivo

Withdrawn and replaced with newer version.

2-262

2-272

USP 42-NF37:2019 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version.

C. Cardiovascular

3-139

3-161

ISO 14117 Second edition 2019-09 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

Withdrawn and replaced with newer version.

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

4-186

4-260

ANSI/ASA S12.2-2019 American National Standard Criteria for Evaluating Room Noise

Withdrawn and replaced with newer version.

4-212

4-261

ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry

Withdrawn and replaced with newer version.

4-229

4-262

IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment—Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

Withdrawn and replaced with newer version.

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

5-103

5-124

ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment—Registered symbols

Withdrawn and replaced with newer version.

5-40

5-125

ISO 14971 Third edition 2019-12 Medical devices—Application of risk management to medical devices

Withdrawn and replaced with newer version.

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

19-13

IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including CORRIGENDUM 1 (2013)]

Transition removed. Recognition restored.

19-32

IEC 62133-1 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications—Part 1: Nickel systems

Transition removed.

19-33

IEC 62133-2 Edition 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications—Part 2: Lithium systems

Transition removed.

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

6-175

6-424

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

Withdrawn and replaced with newer version.

6-254

6-425

ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

Withdrawn and replaced with newer version.

6-293

6-426

ISO 23907-1 First edition 2019-01 Sharps injury protection—Requirements and test methods—Part 1: Single-use sharps containers

Withdrawn and replaced with newer version.

6-335

6-427

ASTM F2101-19 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.

6-412

6-428

USP 42-NF37:2019 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-413

6-429

USP 42-NF37:2019 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-414

6-430

USP 42-NF37:2019 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-415

6-431

USP 42-NF37:2019 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-416

6-432

USP 42-NF37:2019 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-417

6-433

USP 42-NF37:2019 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-418

6-434

USP 42-NF37:2019 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-419

6-435

USP 42-NF37:2019 Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

6-420

6-436

USP 42-NF37:2019 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-226

7-293

CLSI QMS01, 5th ed. June 2019 (Replaces QMS01-A4) A Quality Management System Model for Laboratory Services

Withdrawn and replaced with newer version.

7-281

7-294

CLSI M100, 29th ed. January 2019 (Replaces M100 28th ed.) Performance Standards for Antimicrobial Susceptibility Testing

Withdrawn and replaced with newer version.

I. Materials

8-68

8-519

ISO 13782 Second edition 2019-04 Implants for surgery—Metallic materials—Unalloyed tantalum for surgical implant applications

Withdrawn and replaced with newer version.

8-218

8-520

F799-19 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Withdrawn and replaced with newer version.

8-391

8-521

F2313-18 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide

Withdrawn and replaced with newer version.

8-477

8-522

F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Withdrawn and replaced with newer version.

8-480

ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

Transition period extended.

8-481

ASTM F1314-18 Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

Transition period extended.

8-484

ASTM F2066-18 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Transition period extended.

8-491

ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

Transition period extended.

8-492

ISO 5832-9 Third edition 2019-02 Implants for surgery—Metallic materials—Part 9: Wrought high nitrogen stainless steel

Transition period extended.

8-494

ISO 6474-1 Second edition 2019-03 Implants for surgery—Ceramic materials—Part 1: Ceramic materials based on high purity alumina

Transition period extended.

8-498

ASTM F75-18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

Transition period extended.

8-499

ASTM F1580-18 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

Transition period extended.

8-500

ISO 5832-12 Third edition 2019-02 Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy

Transition period extended.

8-501

ISO 5834-1 Fourth edition 2019-02 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form

Transition period extended.

8-502

ASTM F2038-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

Transition period extended.

8-505

ISO 6474-2 Second edition 2019-03 Implants for surgery—Ceramic materials—Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

Transition period extended.

8-507

ASTM F688-19 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Transition period extended.

8-508

ASTM F2579-18 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

Transition period extended.

8-511

ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

Withdrawn. Duplicate recognition. See 8-471.

8-512

ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Withdrawn. Duplicate recognition. See 8-475.

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)

9-84

9-123

ISO 8600-3 Second edition 2019-08 Endoscopes—Medical endoscopes and endotherapy devices—Part 3: Determination of field of view and direction of view of endoscopes with optics

Withdrawn and replaced with newer version.

M. Ophthalmic

No new entries at this time

N. Orthopedic

11-328

11-360

ASTM F1378-18 ε1 Standard Specification for Shoulder Prostheses

Withdrawn and replaced with newer version.

O. Physical Medicine

16-168

16-207

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability

Withdrawn and replaced with a newer version.

16-169

16-208

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs

Withdrawn and replaced with a newer version.

16-170

16-209

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 3: determination of effectiveness of brakes

Withdrawn and replaced with a newer version.

16-171

16-210

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4 Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range

Withdrawn and replaced with a newer version.

16-172

16-211

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space

Withdrawn and replaced with a newer version.

16-173

16-212

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs

Withdrawn and replaced with a newer version.

16-174

16-213

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of measurement of seating and wheel dimensions

Withdrawn and replaced with a newer version.

16-175

16-214

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths

Withdrawn and replaced with a newer version.

16-176

16-215

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs

Withdrawn and replaced with a newer version.

16-177

16-216

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

Withdrawn and replaced with a newer version.

16-178

16-217

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins

Withdrawn and replaced with a newer version.

16-179

16-218

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces

Withdrawn and replaced with a newer version.

16-180

16-219

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs, scooters and add-on devices—Requirements and test methods

Withdrawn and replaced with a newer version.

16-181

16-220

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling

Withdrawn and replaced with a newer version.

16-182

16-221

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of postural support devices

Withdrawn and replaced with a newer version.

16-183

16-222

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs

Withdrawn and replaced with a newer version.

16-184

16-223

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures

Withdrawn and replaced with a newer version.

16-185

16-224

ANSI/RESNA WC-2:2019 American National Standard for Wheelchairs—Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

Withdrawn and replaced with a newer version.

16-187

16-225

ANSI/RESNA WC-1:2019 American National Standard for Wheelchairs—Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary

Withdrawn and replaced with a newer version.

16-205

ANSI/RESNA W-4:2017 American National Standard for Wheelchairs—Volume 4: Wheelchairs and Transportation

Withdrawn. See 16-226, 16-227, 16-228, and 16-229.

P. Radiology

12-110

12-327

ISO 11551 Third edition 2019-10 Optics and optical instruments—Lasers and laser-related equipment—Test method for absorptance of optical laser components

Withdrawn and replaced with newer version.

12-270

12-328

IEC 61223-3-5 Edition 2.0 2019-09 Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment

Withdrawn and replaced with newer version.

12-308

12-329

IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION 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.

12-309

IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Transition period extended.

12-317

IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including AMENDMENT 2 (2018)]

Transition period extended.

Q. Software/Informatics

13-47

13-110

ISO/IEEE 11073-10101 First edition 2004-12-15 Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature [Including AMENDMENT 1 (2017)]

Withdrawn and replaced with newer version including amendment.

13-48

13-111

IEEE Std 11073-10201-2018 Health informatics—Point-of-care medical device communication Part 10201: Domain Information Model

Withdrawn and replaced with newer version.

R. Sterility

14-325

14-528

ISO 11139 First edition 2018-08 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards

Withdrawn and replaced with newer version.

14-354

14-529

ISO 18472 Second edition 2018-08 Sterilization of health care products—Biological and chemical indicators—Test equipment

Withdrawn and replaced with newer version.

14-382

14-530

ISO/ASTM 51276 Fourth edition 2019-08 Practice for use of a polymethylmethacrylate dosimetry system

Withdrawn and replaced with newer version.

14-520

14-531

USP 42-NF37:2019 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-521

14-532

USP 42-NF37:2019 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-522

14-533

USP 42-NF37:2019 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

14-523

14-534

USP 42-NF37:2019 <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests

Withdrawn and replaced with newer version.

14-524

14-535

USP 42-NF37:2019 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-525

14-536

USP 42-NF37:2019 <55> Biological Indicators—Resistance Performance Tests

Withdrawn and replaced with newer version.

14-526

14-537

USP 42-NF37:2019 <1229.5> Biological Indicators for Sterilization

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: 053. 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

1-145

Lung ventilators and related equipment—Vocabulary and semantics

ISO 19223 First edition 2019-07.

B. Biocompatibility

No new entries at this time

C. Cardiovascular

3-162

Standard Guide for Active Fixation Durability of Endovascular Prostheses

ASTM F3374-19.

3-163

Cardiovascular implants and extracorporeal systems—Centrifugal blood pumps

ISO 18242 First edition 2016-09-01.

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

No new entries at this time

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

No new entries at this time

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

No new entries at this time

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

6-437

Sharps injury protection—Requirements and test methods—Part 2: Reusable sharps containers

ISO 23907-2 First edition 2019-11.

6-438

Medical electrical equipment—Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

IEC 80601-2-77 Edition 1.0 2019-07.

H. In Vitro Diagnostics (IVD)

7-295

Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems

CLSI M52, 1st ed. August 2015.

I. Materials

8-523

Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device

ASTM F3275-19.

8-524

Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device

ASTM F3276-19.

J. Nanotechnology

No new entries at this time

K. Neurology

No new entries at this time

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

No new entries at this time

M. Ophthalmic

No new entries at this time

N. Orthopedic

11-361

Implants for surgery—Wear of total knee prostheses—Part 5: Durability performance of the patellofemoral joint

ISO 14243-5 First edition 2019-05.

11-362

Implants for surgery—Wear of total ankle-joint prostheses—Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test

ISO 22622 First edition 2019-07.

O. Physical Medicine

16-226

American National Standard for Wheelchairs—Volume 4: Wheelchairs and Transportation Section 10 Wheelchair containment and occupant retention systems for use in large accessible transit vehicles: systems for rearward-facing passengers

ANSI/RESNA WC-4:2017 Section 10.

16-227

American National Standard for Wheelchairs—Volume 4: Wheelchairs and Transportation Section 18: Wheelchair tiedown and occupant restraint systems for use in motor vehicles

ANSI/RESNA WC-4:2017 Section 18.

16-228

ANSI/RESNA W-4:2017 American National Standard for Wheelchairs—Volume 4: Wheelchairs and Transportation Section 19: Wheelchairs used as seats in motor vehicles

ANSI/RESNA WC-4:2017 Section 19.

16-229

American National Standard for Wheelchairs—Volume 4: Wheelchairs and Transportation Section 20: Wheelchair seating systems for use in motor vehicles

ANSI/RESNA WC-4:2017 Section 20.

P. Radiology

No new entries at this time

Q. Software/Informatics

13-112

Principles for medical device security—Postmarket risk management for device manufacturers

AAMI TIR97:2019.

R. Sterility

14-538

Standard Guide for Designing Reusable Medical Devices for Cleanability

ASTM F3357-19.

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 listed on FDA's website, which is specifically available at

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/recognition-standard.

Dated: March 24, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

[FR Doc. 2020-06520 Filed 3-27-20; 8:45 am]

BILLING CODE 4164-01-P