12476 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

NDA holder not to avail itself of the 

opportunity for a hearing concerning 

CDER’s proposal to withdraw approval 

of the NDAs and constitutes a waiver of 

any contentions concerning the legal 

status of the drug products. FDA will 

then withdraw approval of the NDAs, 

and the drug products may not 

thereafter be lawfully introduced or 

delivered for introduction into interstate 

commerce. Any new drug product 

introduced or delivered for introduction 

into interstate commerce without an 

approved NDA is subject to regulatory 

action at any time. 

A request for a hearing may not rest 

upon mere allegations or denials but 

must present specific facts showing that 

there is a genuine and substantial issue 

of fact that requires a hearing. If a 

request for a hearing is not complete or 

is not supported, the Commissioner of 

Food and Drugs will enter summary 

judgment against the person who 

requests the hearing, making findings 

and conclusions, and denying a hearing. 

All paper submissions under this 

notice of opportunity for a hearing must 

be filed in two copies. Except for data 

and information prohibited from public 

disclosure under 21 U.S.C. 331(j) or 18 

U.S.C. 1905, the submissions may be 

seen at the Dockets Management Staff 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday, and will 

be posted to the docket at https://

www.regulations.gov. 

This notice is issued under section 

505(e) of the FD&C Act and under 

authority delegated to the Director of 

CDER by the Commissioner of Food and 

Drugs. 

Dated: February 25, 2021. 

Patrizia Cavazzoni, 

Acting Director, Center for Drug Evaluation 

and Research. 

[FR Doc. 2021–04344 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

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: 

054 

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: 054’’ 

(Recognition List Number: 054), 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 3, 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: 054.’’ 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: 054. 

• 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: 054 is available on the internet 

at https://www.fda.gov/MedicalDevices/ 


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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 12477 

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: 054 

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: 054’’ 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-consensusstandards-premarket-submissionsmedical-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-andconformity-assessment-program/federalregister-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-assessmentprogram/federal-register-documents. 

Additional information on the Agency’s 

Standards and Conformity Assessment 

Program is available at https://

www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 054 

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: 054’’ 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: 054. 

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

A. Anesthesiology 

1–98 ....................... 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.Withdrawn and replaced with 

newer version. 

B. Biocompatibility 

2–168 ..................... 2–273 ISO 10993–9 Third edition 2019–11 Biological evaluation of medical 

devices—Part 9: Framework for identification and quantification of 

potential degradation products.

Withdrawn and replaced with 

newer version. Extent of recognition. 

2–197 ..................... 2–274 ASTM F749—20 Standard Practice for Evaluating Material Extracts 

by Intracutaneous Injection in the Rabbit.

Withdrawn and replaced with 

newer version. 

2–238 ..................... ........................ ANSI/AAMI BE83:2006/(R)2011 Biological evaluation of medical devices—Part 18: Chemical characterization of materials.Withdrawn. 

C. Cardiovascular 

3–55 ....................... 3–164 ASTM F1830—19 Standard Practice for Collection and Preparation 

of Blood for Dynamic In Vitro Evaluation of Blood Pumps.

Withdrawn and replaced with 

newer version. 

3–56 ....................... 3–165 ASTM 1841—19 Standard Practice for Assessment of Hemolysis in 

Continuous Flow Blood Pumps.

Withdrawn and replaced with 

newer version. 

3–127 ..................... 3–155 ANSI/AAMI/IEC 60601–2–47:2012/(R)2016 Medical electrical equipment—Part 2–47: Particular requirements for the basic safety and 

essential performance of ambulatory electrocardiographic systems.

Transferred. 

3–142 ..................... 8–525 ISO/TS 17137 Second edition 2019–09 Cardiovascular implants and 

extracorporeal systems—Cardiovascular absorbable implants.

Withdrawn and replaced with 

newer version. Transferred. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

3–152 ..................... 3–123 IEC 80601–2–30: Edition 2.0 2018–03 Medical electrical equipment 

Part 2–30: Particular requirements for basic safety and essential 

performance of automated type non-invasive sphygmomanometers.

Withdrawn and replaced with 

newer version. 

3–160 ..................... 3–166 ISO 81060–2 Third edition 2018–11 Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated 

measurement type [Including AMENDMENT1 (2020)].

Withdrawn and replaced with 

newer version. 

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

4–201 ..................... 4–263 ISO 9693 Third edition 2019–10 Dentistry—Compatibility testing for 

metal-ceramic and ceramic-ceramic systems.

Withdrawn and replaced with 

newer version. 

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

5–110 ..................... 5–126 ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less.Withdrawn and replaced with 

newer version. 

5–111 ..................... 5–127 ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL) 

Shipment.

Withdrawn and replaced with 

newer version. 

5–112 ..................... 5–128 ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of 

Truckload Shipment.

Withdrawn and replaced with 

newer version. 

5–114 ..................... 5–129 IEC 62366–1 Edition 1.1 2020–06 CONSOLIDATED VERSION 

Medical devices—Part 1: Application of usability engineering to 

medical devices.

Withdrawn and replaced with 

newer version. 

5–116 ..................... 5–130 ISO 7010 Third edition 2019–07 Graphical symbols—Safety colours 

and safety signs—Registered safety signs.

Withdrawn and replaced with 

newer version. 

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

No new entries at this time. 

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

6–68 ....................... 6–439 ISO 7886–2 Second edition 2020–04 Sterile hypodermic syringes 

for single use—Part 2: Syringes for use with power-driven syringe 

pumps.

Withdrawn and replaced with 

newer version. 

6–145 ..................... 6–440 ASTM D3578—19 Standard Specification for Rubber Examination 

Gloves.

Withdrawn and replaced with 

newer version. 

6–148 ..................... 6–441 ISO 7886–3 Second edition 2020–05 Sterile hypodermic syringes 

for single use—Part 3: Auto-disabled syringes for fixed-dose immunization.

Withdrawn and replaced with 

newer version. 

6–165 ..................... 6–442 ASTM D6977—19 Standard Specification for Polychloroprene Examination Gloves for Medical Application.Withdrawn and replaced with 

newer version. 

6–168 ..................... 6–443 ASTM D3577—19 Standard Specification for Rubber Surgical 

Gloves.

Withdrawn and replaced with 

newer version. 

6–176 ..................... 6–444 ASTM D7103—19 Standard Guide for Assessment of Medical 

Gloves.

Withdrawn and replaced with 

newer version. 

6–178 ..................... ........................ ASTM D6124—06 (Reapproved 2017) Standard Test Method for 

Residual Powder on Medical Gloves.

Extent of recognition. 

6–183 ..................... 6–445 ASTM D5250—19 Standard Specification for Poly(vinyl chloride) 

Gloves for Medical Application.

Withdrawn and replaced with 

newer version. 

6–244 ..................... 6–446 ASTM D6319—19 Standard Specification for Nitrile Examination 

Gloves for Medical Application.

Withdrawn and replaced with 

newer version. 

6–318 ..................... 6–447 ISO 8536–4 Sixth edition 2019–09 Infusion equipment for medical 

use—Part 4: Infusion sets for single use, gravity feed.

Withdrawn and replaced with 

newer version. 

H. In Vitro Diagnostics (IVD) 

No new entries at this time. 

I. Materials 

8–227 ..................... 8–526 ASTM F2182—19e2 Standard Test Method for Measurement of 

Radio Frequency Induced Heating On or Near Passive Implants 

During Magnetic Resonance Imaging.

Withdrawn and replaced with 

newer version. 

8–343 ..................... 8–527 ASTM F899—20 Standard Specification for Wrought Stainless 

Steels for Surgical Instruments.

Withdrawn and replaced with 

newer version. 

8–349 ..................... 8–528 ASTM F2503—20 Standard Practice for Marking Medical Devices 

and Other Items for Safety in the Magnetic Resonance Environment.

Withdrawn and replaced with 

newer version. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

8–374 ..................... 8–529 ASTM F2633—19 Standard Specification for Wrought Seamless 

Nickel-Titanium Shape Memory Alloy Tube for Medical Devices 

and Surgical Implants.

Withdrawn and replaced with 

newer version. 

8–461 ..................... 8–530 ASTM F3208—19 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) 

No new entries at this time. 

M. Ophthalmic 

No new entries at this time. 

N. Orthopedic 

11–215 ................... 11–363 ASTM F897—19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws.Withdrawn and replaced with 

newer version. 

11–222 ................... 11–364 ISO 14243–1 Second edition 2009–11–15 Implants for surgery— 

Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control 

and corresponding environmental conditions for test [Including 

AMENDMENT1 (2020)].

Withdrawn and replaced with 

newer version. 

11–253 ................... 11–365 ASTM F1800—19e1 Standard Practice for Cyclic Fatigue Testing of 

Metal Tibial Tray Components of Total Knee Joint Replacements.

Withdrawn and replaced with 

newer version. 

11–275 ................... 11–366 ASTM F2381—19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene 

Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy.

Withdrawn and replaced with 

newer version. 

11–292 ................... 11–367 ISO 14243–3 Second edition 2014–11–01 Implants for surgery— 

Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test 

[Including AMENDMENT 1 (2020)].

Withdrawn and replaced with 

newer version. 

O. Physical Medicine 

16–170 ................... ........................ ANSI RESNA WC–1:2009 Section 3 American National Standard for 

Wheelchairs—Volume 1: Additional Requirements for Wheelchairs 

(including Scooters) Section 3: Determination of effectiveness of 

brakes.

Title change. 

P. Radiology 

12–287 ................... 12–330 NEMA Standards Publication XR 28–2018 Supplemental Requirements for User Information and System Function Related to Dose 

in CT.

Withdrawn and replaced with 

newer version. 

12–325 ................... ........................ NEMA Standards Publication XR 25–2019 Computed Tomography 

Dose Check.

Transition period extended. 

Q. Software/Informatics 

13–80 ..................... 13–113 IEEE Std 11073–20601–2019 Health informatics—Personal health 

device communication—Part 20601: Application profile—Optimized exchange protocol.

Withdrawn and replaced with 

newer version. 

13–110 ................... 13–114 IEEE Std 11073–10101–2019 Health informatics—Point-of-care 

medical device communication—Part 10101: Nomenclature.

Withdrawn and replaced with 

newer version. 

R. Sterility 

14–313 ................... 14–539 ASTM F2475—20 Standard Guide for Biocompatibility Evaluation of 

Medical Device Packaging Materials.

Withdrawn and replaced with 

newer version. 


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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

14–327 ................... 14–540 ISO 11737–2 Third edition 2019–12 Sterilization of health care products—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.Withdrawn and replaced with 

newer version. 

14–360 ................... 14–541 ANSI/AAMI ST72:2019 Bacterial endotoxins—Test methods, routine 

monitoring, and alternatives to batch testing.

Withdrawn and replaced with 

newer version. 

14–408 ................... 2–275 ISO 10993–7 Second edition 2008–10–15 Biological evaluation of 

medical devices—Part 7: Ethylene oxide sterilization residuals [Including Corrigendum 1 (2009) and AMENDMENT 1 (2020)].

Withdrawn and replaced with 

newer version. Transferred. 

14–436 ................... 14–542 ISO/ASTM 52628 Second edition 2020–04 Standard practice for dosimetry in radiation processing.Withdrawn and replaced with 

newer version. 

14–515 ................... ........................ ISO 17664 Second edition 2017–10 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.Extent of recognition. 

14–528 ................... 14–543 ISO 11139 First edition 2018–08 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards.New recognition number. 

14–529 ................... 14–544 ISO 18472 Second edition 2018–08 Sterilization of health care products—Biological and chemical indicators—Test equipment.New recognition number. 

14–530 ................... 14–545 ISO/ASTM 51276 Fourth edition 2019–08 Practice for use of a 

polymethylmethacrylate dosimetry system.

New recognition number. 

14–531 ................... 14–546 USP 42–NF37:2019 <61> Microbiological Examination of Nonsterile 

Products: Microbial Enumeration Tests.

New recognition number. 

14–532 ................... 14–547 USP 42–NF37:2019 <71> Sterility Tests ............................................ New recognition number. 

14–533 ................... 14–548 USP 42–NF37:2019 <85> Bacterial Endotoxins Test ......................... New recognition number.

S. Tissue Engineering 

15–19 ..................... 15–59 ASTM F2450—18 Standard Guide for Assessing Microstructure of 

Polymeric Scaffolds for Use in Tissue-Engineered Medical Products.

Withdrawn and replaced with 

newer version. 

15–30 ..................... 15–60 ASTM F2212—19 Standard Guide for Characterization of Type I 

Collagen as Starting Material for Surgical Implants and Substrates 

for Tissue Engineered Medical Products (TEMPs).

Withdrawn and replaced with 

newer version. 

15–39 ..................... 15–61 ASTM F2150 19 Standard Guide for Characterization and Testing of 

Biomaterial Scaffolds Used in Regenerative Medicine and TissueEngineered Medical Products.

Withdrawn and replaced with 

newer version. 

15–41 ..................... 15–62 ASTM F2602—18 Standard Test Method for Determining the Molar 

Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).

Withdrawn and replaced with 

newer version. 

15–50 ..................... 15–63 ASTM F2739—19 Standard Guide for Quantifying Cell Viability and 

Related Attributes within Biomaterial Scaffolds.

Withdrawn and replaced with 

newer version. 

1All 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: 054. 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 

2–276 .................. Biological evaluation of medical devices—Part 18: Chemical characterization of 

medical device materials within a risk management process.

ISO 10993–18 Second edition 2020–01. 

C. Cardiovascular 

3–167 .................. Non-invasive sphygmomanometers—Part 5: Requirements for the repeatability 

and reproducibility of NIBP simulators for testing of automated non-invasive 

sphygmomanometers.

ISO/TS 81060–5 First edition 2020–02. 


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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

3–168 .................. Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including 

Amendment 1 (2019)].

IEEE Std 1708–2014. 

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) 

No new entries at this time. 

H. In Vitro Diagnostics (IVD) 

7–296 .................. Measurement Procedure Comparison and Bias Estimation Using Patient Samples.CLSI EP09c 3rd Edition. 

7–297 .................. Medical laboratories—Practical guidance for the estimation of measurement uncertainty.ISO/TS 20914 First edition 2019–07. 

7–298 .................. Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures.CLSI EP35 1st Edition. 

I. Materials 

8–531 .................. Standard Guide for Methods of Extraction of Test Soils for the Validation of 

Cleaning Methods for Reusable Medical Devices.

ASTM F3321—19. 

8–532 .................. Standard Guide for Assessing the Removal of Additive Manufacturing Residues 

in Medical Devices Fabricated by Powder Bed Fusion.

ASTM F3335—20. 

8–533 .................. Additive Manufacturing—Feedstock materials—Methods to characterize metal 

powders.

ISO/ASTM 52907: First Edition 2019– 

11. 

8–534 .................. Additive Manufacturing—Design—Part 1: Laser-based powder bed fusion of metals.ISO/ASTM 52911–1: First Edition 2019– 

07. 

8–535 .................. Additive Manufacturing—Design—Part 2: Laser-based powder bed fusion of polymers.ISO/ASTM 52911–2: First Edition 2019– 

09. 

8–536 .................. Additive Manufacturing—Test Artifacts—Geometric capability assessment of additive manufacturing systems.ISO/ASTM 52902: First Edition 2019– 

07. 

J. Nanotechnology 

18–15 .................. Standard Guide for Tiered Approach to Detection and Characterization of Silver 

Nanomaterials in Textiles..

ASTM E3025—16. 

18–16 .................. Nanotechnologies—Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation.ISO/TS 21362 First edition 2018–06. 

K. Neurology 

No new entries at this time. 

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

9–124 .................. Colorimetry—Part 1: CIE standard colorimetric observers ...................................... ISO/CIE 11664–1 First edition 2019–06. 

9–125 .................. Colorimetry—Part 2: CIE standard illuminants ........................................................ ISO 11664–2 CIE S 014–2/E First edition 2007–10–15 Corrected version 

2008–11–01. 

9–126 .................. Colorimetry—Part 3: CIE tristimulus values ............................................................. ISO/CIE 11664–3 First edition 2019–06. 

9–127 .................. Colorimetry—Part 4: CIE 1976 L*a*b* colour space ............................................... ISO/CIE 11664–4 First edition 2019–06. 

9–128 .................. Colorimetry—Part 6: CIEDE2000 colour-difference formula .................................... ISO/CIE 11664–6 First edition 2014–02– 

01. 

9–129 .................. Multimedia systems and equipment—Colour measurement and management— 

Part 2–1: Colour management—Default RGB colour space—sRGB [Including 

Amendment 1 (2003) and Corrigendum 1 (2014)].

IEC 61966–2–1 First edition 1999–10. 


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12482 Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference No. and date 

M. Ophthalmic 

No new entries at this time. 

N. Orthopedic 

11–368 ................ Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total 

Knee Tibial Components.

ASTM F3334—19. 

11–369 ................ Standard Practice for Inspection of Spinal Implants Undergoing Testing ............... ASTM F3292—19. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–331 ................ Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance 

Imaging Systems.

NEMA Standards Publication MS 14– 

2019. 

12–332 ................ Magnetic resonance equipment for medical imaging—Part 1: Determination of 

essential image quality parameters.

IEC 62464–1 Edition 2.0 2018–12. 

12–333 ................ Guidance on error and warning messages for software used in radiotherapy ....... IEC TR 63183 Edition 1.0 2019–12. 

12–334 ................ Radiation therapy machine characterization ............................................................ AAMI RT3:2020. 

Q. Software/Informatics 

13–115 ................ Software and systems engineering—Software testing—Part 1: Concepts and definitions.ISO/IEC/IEEE 29119–1 First edition 

2013–09–01. 

R. Sterility 

14–549 ................ Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne 

Ultrasound.

ASTM F3004—13e1. 

S. Tissue Engineering 

No new entries at this time. 

1All 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/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process. 

Dated: February 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–04376 Filed 3–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1638] 

Lawrence B. Ryan: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Lawrence B. 

Ryan from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Mr. Ryan was convicted of 

a felony under Federal law for conduct 

that relates to the regulation of a drug 

product under the FD&C Act. Mr. Ryan 

was given notice of the proposed 

permanent debarment and an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

October 18, 2020 (30 days after receipt 

of the notice), Mr. Ryan had not 

responded. Mr. Ryan’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is applicable March 3, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 


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