Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052

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: 052

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: 052” (Recognition List Number: 052), 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 October 24, 2019.

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: 052.” 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: 052.

• 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.gpo.gov/fdsys/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: 052 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: 052 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: 052” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 5514, 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. 5514, 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 hypertext markup language (HTML) and portable document format (PDF) versions 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: 052

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: 052” 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: 052.

Table 1—Modifications to the List of Recognized Standards

Old

Recognition

No.

Replacement Recognition No.

Title of standard

1

Change

A. Anesthesiology

1-116

ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers—Agent specific filling systems

Extent of Recognition.

1-122

ISO 5364 Fifth edition 2016-09-01 Anaesthetic and respiratory equipment—Oropharyngeal airways

Extent of Recognition.

1-125

ISO 8836 Fourth edition 2014-10-15 Suction catheters for use in the respiratory tract

Extent of Recognition.

1-126

ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment—Supralaryngeal airways and connectors

Extent of Recognition.

1-131

1-142

ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment—Part 1: Electrically powered suction equipment [Including AMENDMENT 1 (2018)]

Withdrawn and replaced with newer version including amendment.

B. Biocompatibility

2-162

2-263

ASTM F1903-18 Standard Practice for Testing for Cellular Responses to Particles in vitro

Withdrawn and replaced with newer version.

2-206

2-264

ASTM F2148-18 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

Withdrawn and replaced with newer version.

2-223

2-265

ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

Withdrawn and replaced with newer version.

2-257

2-266

ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

Withdrawn and replaced with newer version.

C. Cardiovascular

3-122

3-160

ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type

Withdrawn and replaced with newer version.

3-123

IEC 80601-2-30 Edition 2.0 2018-03 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Extent of Recognition.

3-137

ASTM F3036-13 Standard Guide for Testing Absorbable Stents

Extent of Recognition.

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

4-182

4-258

ISO 10139-2 Third edition 2016-06-15 Dentistry—Soft lining materials for removable dentures—Part 2: Materials for long-term use

Withdrawn and replaced with newer version.

4-196

ISO 6872 Third edition 2008-09-01 Dentistry—Ceramic materials

Withdrawn. See #4-223.

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

5-109

5-123

ISO 80369-3 First edition 2016-07-01 Small-bore connectors for liquids and gases in healthcare applications —Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]

Withdrawn and replaced with newer version including amendment.

5-115

ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications—Part 7: Connectors for intravascular or hypodermic applications

Transition removed.

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

No new entries at this time

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

Transition removed. Recognition restored.

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

Transition removed. Recognition restored.

6-403

6-421

ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement [Including AMENDMENT 1 (2018)]

Withdrawn and replaced with newer version including amendment.

H. In Vitro Diagnostics (IVD)

7-215

7-287

CLSI M44-S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement

Withdrawn and replaced with newer version.

7-222

7-288

CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria,

Nocardia

spp., and Other Aerobic Actinomycetes

Withdrawn and replaced with newer version.

7-274

7-289

CLSI MM17 2nd Edition Validation and Verification of Multiplex Nucleic Acid Assays

Withdrawn and replaced with newer version.

I. Materials

8-132

8-491

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

Withdrawn and replaced with newer version.

8-150

8-492

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

Withdrawn and replaced with newer version.

8-188

8-493

ISO 13779-2 Third edition 2018-12 Implants for surgery—Hydroxyapatite—Part 2: Thermally sprayed coatings of hydroxyapatite

Withdrawn and replaced with newer version.

8-194

8-494

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

Withdrawn and replaced with newer version.

8-213

8-495

ISO 5834-3 Second edition 2019-02 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methods

Withdrawn and replaced with newer version.

8-214

8-496

ISO 5834-4 Second edition 2019-02 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4: Oxidation index measurement method

Withdrawn and replaced with newer version.

8-215

8-497

ISO 5834-5 Second edition 2019-02 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method

Withdrawn and replaced with newer version.

8-229

8-498

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

Withdrawn and replaced with newer version.

8-331

8-499

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

Withdrawn and replaced with newer version.

8-351

8-500

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

Withdrawn and replaced with newer version.

8-352

8-501

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

Withdrawn and replaced with newer version.

8-359

8-502

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

Withdrawn and replaced with newer version.

8-360

8-503

ASTM F2042-18 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

Withdrawn and replaced with newer version.

8-370

8-504

ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

Withdrawn and replaced with newer version.

8-388

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

Withdrawn and replaced with newer version.

8-397

8-506

ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

Withdrawn and replaced with newer version.

8-402

8-507

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

Withdrawn and replaced with newer version.

8-411

8-508

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

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

10-89

ANSI Z80.7-2013 (R2018) American National Standard for Ophthalmic Optics—Intraocular Lenses

Extent of recognition.

N. Orthopedic

11-250

11-349

ISO 14242-3 First edition 2009-03-15 Implants for surgery—Wear of total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]

Withdrawn and replaced with newer version.

11-251

11-350

ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

Withdrawn and replaced with newer version.

11-273

11-351

ISO 18192-1 Second edition 2011-03-01 Implants for surgery—Wear of total intervertebral spinal disc prostheses—Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]

Withdrawn and replaced with newer version.

11-291

11-352

ISO 14242-1 Third edition 2014-10-15 Implants for surgery—Wear of total hip-joint prostheses —Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]

Withdrawn and replaced with newer version including amendment.

O. Physical Medicine

No new entries at this time

P. Radiology

12-225

12-325

NEMA XR 25-2019 Computed Tomography Dose Check

Withdrawn and replaced with newer version.

12-265

12-326

NEMA NU 2-2018 Performance Measurements of Positron Emission Tomographs (PETS)

Withdrawn and replaced with newer version.

Q. Software/Informatics

No new entries at this time

R. Sterility

14-377

14-527

ASTM F2638-18 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.

14-428

14-528

ISO 11137-1 First edition 2006-04-15 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including AMENDMENT 1 (2013) and AMENDMENT 2 (2018)]

Withdrawn and replaced with newer version including amendment.

14-452

14-529

ISO 11135 Second edition 2014-07-15 Sterilization of health-care products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: AMENDMENT 1 (2018)]

Withdrawn and replaced with newer version including amendment.

14-454

14-530

ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Withdrawn and replaced with newer version.

14-455

14-531

ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes

Withdrawn and replaced with newer version.

S. Tissue Engineering

15-27

15-57

F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

Withdrawn and replaced with newer version.

15-28

15-58

F2103-18 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

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: 052. 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

1-143

Medical electrical equipment—Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

ISO 80601-2-79 First edition 2018-07.

1-144

Medical electrical equipment—Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

ISO 80601-2-80 First edition 2018-07.

B. Biocompatibility

2-267

Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials

ASTM F2888—19.

2-268

Biological evaluation of medical devices—Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

ISO/TS 21726 First edition 2019-02.

C. Cardiovascular

No new entries at this time

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

4-259

Dentistry—Implants—Dynamic loading test for endosseous dental implants

ISO 14801 Third edition

2016-11-01.

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

No new entries at this time

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

19-35

Standard for Standby Batteries

UL 1989 Edition 5, 2013-10-02, ANSI November 2018.

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

6-422

Medical device safety assurance case guidance

AAMI TIR38:2019.

6-423

CONSOLIDATED VERSION Medical electrical equipment—Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

IEC 60601-2-6 Edition 2.1 2016-04.

H. In Vitro Diagnostics (IVD)

7-290

Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking

CLSI EP34 1st Edition.

7-291

How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

CLSI EP27-A Vol. 32 No. 12, Replaces EP27-P Vol. 29 No. 16.

7-292

Performance Standards for Susceptibility Testing of Mycobacteria,

Nocardia

spp., and other Aerobic Actinomycetes

CLSI M62 1st Edition.

I. Materials

8-509

Standard Specification for Polysulfone Resin for Medical Applications

ASTM F702—18.

8-510

Standard Specification for Polycarbonate Resin for Medical Applications

ASTM F997—18.

8-511

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

ASTM F1925—17.

8-512

Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

ASTM F2026—17.

8-513

Implants for surgery—Metallic materials—Classification of microstructures for alpha+beta titanium alloy bars

ISO 20160 First edition 2006-05-01.

8-514

Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms

ISO 5834-2 Fifth edition 2019-02.

8-515

Implants for surgery—Hydroxyapatite—Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

ISO 13779-3 Second edition 2018-12.

8-516

Implants for surgery—Hydroxyapatite—Part 4: Determination of coating adhesion strength

ISO 13779-4 Second edition 2018-12.

8-517

Non-active surgical implants—Implant coating—Part 1: General requirements

ISO 17327-1 First edition 2018-02.

8-518

Standard Test Method for Ion Release Evaluation of Medical Implants

ASTM F3306—19.

J. Nanotechnology

18-13

Nanotechnologies—Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials

ISO/TS 18827 First edition 2017-06.

18-14

Nanotechnologies—Methodology for the classification and categorization of nanomaterials

ISO/TR 11360 First edition 2010-07-15.

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

10-116

American National Standard for Ophthalmics—Extended Depth of Focus Intraocular Lenses

ANSI Z80.35-2018.

10-117

American National Standard for Ophthalmics—Slit-Lamp Microscopes

ANSI Z80.37-2017.

10-118

American National Standard for Ophthalmics—Light Hazard from Operation Microscopes Used in Ocular Surgery

ANSI Z80.38-2017.

N. Orthopedic

11-353

Implants for surgery—Wear of total intervertebral spinal disc prostheses —Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions

ISO 18192-3 First edition 2017-06.

11-354

Standard Guide for Impingement Testing of Total Disc Prostheses

ASTM F3295—18.

11-355

Implants for surgery—Metal intramedullary nailing systems—Part 1: Intramedullary nails

ISO 15142-1 First edition 2003-08-01.

11-356

Implants for surgery—Metal intramedullary nailing systems—Part 2: Locking components

ISO 15142-2 First edition 2003-08-01.

11-357

Implants for surgery—Metal intramedullary nailing systems—Part 3: Connection devices and reamer diameter instruments

ISO 15142-3 First edition 2003-08-01.

11-358

Implants for surgery—Wear of total hip-joint prostheses—Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading

ISO 14242-4 First edition 2018-05.

11-359

Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination of resistance to static load of modular femoral heads

ISO 7206-10 Second edition 2018-08.

O. Physical Medicine

16-206

Wheelchairs—Part 30: Wheelchairs for changing occupant posture—Test methods and requirements

ISO 7176-30 First edition 2018-12.

P. Radiology

No new entries at this time

Q. Software/Informatics

13-108

Health informatics—Point-of-care medical device communication—Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding

IEEE Std 11073-20701-2018.

13-109

(American National Standard) Standard for Safety for Medical Device Interoperability

ANSI/AAMI/UL 2800-1: 2019.

R. Sterility

14-532

Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method

ASTM F3287—17e1.

14-533

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10

−6

ISO/TS 19930 First edition 2017-12.

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 following information available at

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

Dated: October 18, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

[FR Doc. 2019-23198 Filed 10-23-19; 8:45 am]

BILLING CODE 4164-01-P