Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24175 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

057 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a publication containing 

modifications the Agency is making to 

the list of standards FDA recognizes for 

use in premarket reviews (FDA 

Recognized Consensus Standards). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 057’’ 

(Recognition List Number: 057), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit either electronic or 

written comments on the notice at any 

time. These modifications to the list of 

recognized standards are applicable 

April 22, 2022. 

ADDRESSES: You may submit comments 

on the current list of FDA Recognized 

Consensus Standards at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2004–N–0451 for ‘‘Food and Drug 

Administration Modernization Act of 

1997: Modifications to the List of 

Recognized Standards, Recognition List 

Number: 057.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. FDA will 

consider any comments received in 

determining whether to amend the 

current listing of modifications to the 

list of recognized standards, Recognition 

List Number: 057. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION’’. The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

An electronic copy of Recognition List 

Number: 057 is available on the internet 

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

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. See section 

IV for electronic access to the searchable 

database for the current list of FDArecognized consensus standards, 

including Recognition List Number: 057 

modifications and other standardsrelated information. Submit written 

requests for a single hard copy of the 

document entitled ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 057’’ to Scott 

Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5606, Silver Spring, 

MD 20993, 301–796–6287. Send one 

self-addressed adhesive label to assist 

that office in processing your request, or 

Fax your request to 301–847–8144. 

FOR FURTHER INFORMATION CONTACT: 

Scott Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5606, Silver Spring, 

MD 20993, 301–796–6287, 

CDRHStandardsStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) amended section 

514 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

360d). Amended section 514 allows 

FDA to recognize consensus standards 

developed by international and national 

organizations for use in satisfying 

portions of device premarket review 

submissions or other requirements. 

In the Federal Register of September 

14, 2018 (83 FR 46738), FDA announced 

the availability of a guidance entitled 

‘‘Appropriate Use of Voluntary 

Consensus Standards in Premarket 

Submissions for Medical Devices.’’ The 

guidance describes how FDA has 

implemented its standards recognition 


lotter on DSK11XQN23PROD with NOTICES1
24176 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

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: 057 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the Agency 

is recognizing for use in premarket 

submissions and other requirements for 

devices. FDA is incorporating these 

modifications to the list of FDA 

Recognized Consensus Standards in the 

Agency’s searchable database. FDA is 

using the term ‘‘Recognition List 

Number: 057’’ to identify the current 

modifications. 

In table 1, FDA describes the 

following modifications: (1) The 

withdrawal of standards and their 

replacement by others, if applicable; (2) 

the correction of errors made by FDA in 

listing previously recognized standards; 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III, FDA lists modifications 

the Agency is making that involve new 

entries and consensus standards added 

as modifications to the list of recognized 

standards under Recognition List 

Number: 057. 

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

A. Anesthesiology 

No new entries at this time. 

B. Biocompatibility 

2–275 ......... ........................ ISO 10993–7 Second edition 2008–10–15 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals [Including: 

Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)].

Title change. 

2–284 ......... 2–292 USP–NF M98833_01_01 <87> Biological Reactivity Test, In Vitro—Direct 

Contact Test.

Withdrawn and replaced with newer 

version. 

2–285 ......... 2–293 USP–NF M98833_01_01 <87> Biological Reactivity Test, In Vitro— 

Elution Test.

Withdrawn and replaced with newer 

version. 

2–286 ......... 2–294 USP–NF M98834_01_01 <88> Biological Reactivity Tests, In Vivo ........... Withdrawn and replaced with newer 

version. 

2–287 ......... 2–295 USP–NF M98900_01_01 <151> Pyrogen Test (USP Rabbit Test). ........... Withdrawn and replaced with newer 

version. 

C. Cardiovascular 

3–88 ........... 3–171 ASTM F2514–21 Standard Guide for Finite Element Analysis (FEA) of 

Metallic Vascular Stents Subjected to Uniform Radial Loading.

Withdrawn and replaced with newer 

version. 

3–99 ........... 3–172 AAMI TIR42:2021 Evaluation of particulate associated with vascular medical devices.Withdrawn and replaced with newer 

version. 

3–133 ......... 3–173 ISO 5840–3 Second edition 2021–01 Cardiovascular implants—Cardiac 

valve prostheses—Part 3: Heart valve substitutes implanted by 

transcatheter techniques.

Withdrawn and replaced with newer 

version. 

3–145 ......... 3–174 ISO 5840–1 Second edition 2021–01 Cardiovascular implants—Cardiac 

valve prostheses—Part 1: General requirements.

Withdrawn and replaced with newer 

version. 

3–147 ......... 3–175 ISO 5840–2 Second edition 2021–01 Cardiovascular implants—Cardiac 

valve prostheses—Part 2: Surgically implanted heart valve substitutes.

Withdrawn and replaced with newer 

version. 

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

4–89 ........... ........................ ANSI/ADA Standard No. 53—2008 (R2013) Polymer-Based Crown and 

Bridge Materials.

Withdrawn. 

4–282 ......... 4–284 ISO 10873 Second edition 2021–07 Dentistry—Denture adhesives .......... Withdrawn and replaced with newer 

version. 


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Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24177 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

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

5–117 ......... 5–134 ISO 15223–1 Fourth edition 2021–07 Medical devices—Symbols to be 

used with medical device labels, labelling, and information to be supplied—Part 1: General requirements.

Withdrawn and replaced with newer 

version. 

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

19–34 ......... 19–41 ANSI/UL 61010–1 3rd Ed, dated May 12, 2012 with revision through July 

19, 2019 Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements.

Withdrawn and replaced with newer 

version. 

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

6–365 ......... 6–464 ISO 11040–4 Third edition 2015–04–01 Prefilled syringes—Part 4: Glass 

barrels for injectables and sterilized subassembled syringes ready for 

filling [Including AMENDMENT 1 (2020)].

Withdrawn and replaced with newer 

version. 

6–451 ......... 6–465 USP–NF M76090_03_01 Sodium Chloride Irrigation .................................. Withdrawn and replaced with newer 

version. 

6–452 ......... 6–466 USP–NF M76070_03_01 Sodium Chloride Injection ................................... Withdrawn and replaced with newer 

version. 

6–453 ......... 6–467 USP–NF M80200_04_01 Nonabsorbable Surgical Suture .......................... Withdrawn and replaced with newer 

version. 

6–454 ......... 6–468 USP–NF M99670_02_01 <881> Tensile Strength ...................................... Withdrawn and replaced with newer 

version. 

6–455 ......... 6–469 USP–NF M99650_02_01 <861> Sutures—Diameter .................................. Withdrawn and replaced with newer 

version. 

6–456 ......... 6–470 USP–NF M99660_03_01 <871> Sutures—Needle Attachment .................. Withdrawn and replaced with newer 

version. 

6–457 ......... 6–471 USP–NF M88880_05_01 Sterile Water for Irrigation .................................. Withdrawn and replaced with newer 

version. 

6–458 ......... 6–472 USP–NF M36660_04_01 Heparin Lock Flush Solution. ............................. Withdrawn and replaced with newer 

version. 

6–459 ......... 6–473 USP–NF M80190_04_01 Absorbable Surgical Suture ................................ Withdrawn and replaced with newer 

version. 

H. In Vitro Diagnostics (IVD) 

No new entries at this time. 

I. Materials 

8–103 ......... 8–563 ASTM F1801–20 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials.Withdrawn and replaced with newer 

version. 

8–121 ......... 8–564 ASTM F2005–21 Standard Terminology for Nickel-Titanium Shape Memory Alloys.Withdrawn and replaced with newer 

version. 

8–193 ......... 8–565 ASTM F2754/F2754M–21 Standard Test Method for Measurement of 

Camber Cast Helix and Direction of Helix of Coiled Wire.

Withdrawn and replaced with newer 

version. 

8–346 ......... 8–566 ASTM F1813–21 Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS 

R58120).

Withdrawn and replaced with newer 

version. 

8–353 ......... 8–567 ASTM F86–21 Standard Practice for Surface Preparation and Marking of 

Metallic Surgical Implants.

Withdrawn and replaced with newer 

version. 

8–355 ......... 8–568 ASTM F1586–21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless 

Steel Bar for Surgical Implants (UNS S31675).

Withdrawn and replaced with newer 

version. 

8–385 ......... 8–569 ASTM F648–21 Standard Specification for Ultra-High-Molecular-Weight 

Polyethylene Powder and Fabricated Form for Surgical Implants.

Withdrawn and replaced with newer 

version. 

8–398 ......... 8–570 ASTM F1108–21 Standard Specification for Titanium-6Aluminum4Vanadium Alloy Castings for Surgical Implants.Withdrawn and replaced with newer 

version. 

8–422 ......... 8–571 ASTM F2052–21 Standard Test Method for Measurement of Magnetically 

Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.

Withdrawn and replaced with newer 

version. 

8–423 ......... 8–572 ASTM F2565–21 Standard Guide for Extensively Irradiation-Crosslinked 

Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications.

Withdrawn and replaced with newer 

version. 

8–424 ......... 8–573 ASTM F2695–12(2020) Standard Specification for Ultra-High Molecular 

Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin 

E) and Fabricated Forms for Surgical Implant Applications.

Withdrawn and replaced with newer 

version. 


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24178 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

8–425 ......... 8–574 ASTM F2820–12(2021)e1 Standard Specification for 

Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications.

Withdrawn and replaced with newer 

version. 

8–443 ......... 8–575 ASTM F3160–21 Standard Guide for Metallurgical Characterization of 

Absorbable Metallic Materials for Medical Implants.

Withdrawn and replaced with newer 

version. 

8–450 ......... 8–576 ASTM F451–21 Standard Specification for Acrylic Bone Cement .............. Withdrawn and replaced with newer 

version. 

8–456 ......... 8–577 ISO 13179–1 Second Edition 2021–09 Implants for surgery—Coatings on 

metallic surgical implants—Part 1: Plasma-sprayed coatings derived 

from titanium or titanium-6 aluminum-4 vanadium alloy powders.

Withdrawn and replaced with newer 

version. Title change. 

8–460 ......... 8–578 ASTM F2848–21 Standard Specification for Medical-Grade Ultra-HighMolecular-Weight Polyethylene Yarns.Withdrawn and replaced with newer 

version. 

8–515 ......... 8–579 ISO 13779–3 Second Edition 2018–12 Implants for surgery— 

Hydroxyapatite—Part 3: Chemical analysis and characterization of 

crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)].

Withdrawn and replaced with newer 

version. 

J. Nanotechnology 

No new entries at this time. 

K. Neurology 

No new entries at this time. 

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

No new entries at this time. 

M. Ophthalmic 

10–73 ......... 10–127 ANSI Z80.21–2020 American National Standard for Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts.Withdrawn and replaced with newer 

version. 

10–87 ......... 10–128 ASTM D882–18 Standard Test Method for Tensile Properties of Thin 

Plastic Sheeting.

Withdrawn and replaced with newer 

version. 

10–88 ......... 10–129 ASTM D790–17 Standard Test Methods for Flexural Properties of 

Unreinforced and Reinforced Plastics and Electrical Insulating Materials.

Withdrawn and replaced with newer 

version. 

10–102 ....... 10–130 ANSI Z80.36–2021 American National Standard for Ophthalmics—Light 

Hazard Protection for Ophthalmic Instruments.

Withdrawn and replaced with newer 

version. 

N. Orthopedic 

11–239 ....... 11–385 ASTM F2345–21 Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads.Withdrawn and replaced with newer 

version. 

11–266 ....... 11–386 ASTM F2665–21 Standard Specification for Total Ankle Replacement 

Prosthesis.

Withdrawn and replaced with newer 

version. 

11–305 ....... 11–387 ASTM F1781–21 Standard Specification for Elastomeric Flexible Hinge 

Finger Total Joint Implants.

Withdrawn and replaced with newer 

version. 

11–345 ....... 11–388 ASTM F1717–21 Standard Test Methods for Spinal Implant Constructs in 

a Vertebrectomy Model.

Withdrawn and replaced with newer 

version. 

11–359 ....... 11–389 ISO 7206–10 Second edition 2018–08 Implants for surgery—Partial and 

total hip-joint prostheses—Part 10: Determination of resistance to static 

load of modular femoral heads [Including AMENDMENT 1 (2021)].

Withdrawn and replaced with newer 

version. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–299 ....... 12–341 IEC 62563–1 Edition 1.2 2021–07 CONSOLIDATED VERSION Medical 

electrical equipment—Medical image display systems—Part 1: Evaluation methods.

Withdrawn and replaced with newer 

version. 

12–300 ....... 12–342 NEMA DICOM PS 3.1—3.20 2021e Digital Imaging and Communications 

in Medicine (DICOM) Set.

Withdrawn and replaced with newer 

version. 


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Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24179 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

Q. Software/Informatics 

13–46 ......... ........................ ASTM F2761–09 (2013) Medical Devices and Medical Systems—Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and 

conceptual model.

Withdrawn. See 13–120. 

R. Sterility 

14–424 ....... 14–563 ISO 13408–6 Second edition 2021–04 Aseptic processing of health care 

products—Part 6: Isolator systems.

Withdrawn and replaced with newer 

version. 

14–555 ....... 14–564 USP–NF M98910_01_01 <161> Medical Devices-Bacterial Endotoxin and 

Pyrogen Tests.

Withdrawn and replaced with newer 

version. 

14–556 ....... 14–565 USP–NF M98802_01_01 <62> Microbiological Examination of Nonsterile 

Products: Tests for Specified Microorganisms.

Withdrawn and replaced with newer 

version. 

14–557 ....... 14–566 USP–NF M98795_02_01 <55> Biological Indicators—Resistance Performance Tests.Withdrawn and replaced with newer 

version. 

14–558 ....... 14–567 USP–NF M7414_01_01 <1229.5> Biological Indicators for Sterilization .... Withdrawn and replaced with newer 

version. 

14–559 ....... 14–568 USP–NF M98800_01_01 <61> Microbiological Examination of Nonsterile 

Products: Microbial Enumeration Tests.

Withdrawn and replaced with newer 

version. 

14–560 ....... 14–569 USP–NF M98810_01_01 <71> Sterility Tests ............................................. Withdrawn and replaced with newer 

version. 

14–561 ....... 14–570 USP–NF M98830_02_01 <85> Bacterial Endotoxins Test ......................... Withdrawn and replaced with newer 

version. 

S. Tissue Engineering 

15–29 ......... ........................ ASTM F2259–10 (Reapproved 2012)e1 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton 

Nuclear Magnetic Resonance (1H NMR) Spectroscopy.

Withdrawn. 

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: 057. These entries are of 

standards not previously recognized by 

FDA. 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition 

No. Title of standard 1 Reference No. and date 

A. Anesthesiology 

No new entries at this time. 

B. Biocompatibility 

No new entries at this time. 

C. Cardiovascular 

3–176 ......... Cardiovascular implants and artificial organs—Cannulae for extracorporeal circulation ISO 18193 First edition 2021–08. 

3–177 ......... Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and 

Stent Systems.

ASTM F2606–08 (Reapproved 2021). 

3–178 ......... Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents.ASTM F3067–14 (Reapproved 2021). 

3–179 ......... Standard Guide for Design Verification Device Size and Sample Size Selection for 

Endovascular Devices.

ASTM F3172–15 (Reapproved 2021). 

3–180 ......... Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance .......... ASTM F3505–21. 

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

4–285 ......... Dental Abrasive Powders ............................................................................................... ANSI/ADA Standard No. 37—1986 

(R2020). 

4–286 ......... Dental Impression Trays ................................................................................................. ANSI/ADA Standard No. 87—1995 

(R2014). 


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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 

4–287 ......... Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products— 

Oral Rinses).

ANSI/ADA Standard No. 116—2020. 

4–288 ......... Dentistry—Mixing machines for dental amalgam ........................................................... ISO 7488 Second edition 2018–04. 

4–289 ......... Dentistry—Intraoral spatulas ........................................................................................... ISO 18556 First edition 2016–04. 

4–290 ......... Dentistry—Integrated dental floss and handles .............................................................. ISO 28158 Second edition 2018–09. 

4–291 ......... Dentistry—Products for external tooth bleaching ........................................................... ISO 28399 First edition 2011–01. 

4–292 ......... Dentistry—Screening method for erosion potential of oral rinses on dental hard tissues.ISO 28888 First edition 2013–10. 

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

No new entries at this time. 

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

19–42 ......... Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 1: General requirements.IEC 61326–1 Edition 3.0 2020–10. 

19–43 ......... Electrical equipment for measurement, control and laboratory use—EMC requirements—Part 2–6: Particular requirements—In vitro diagnostic (IVD) medical equipment.IEC 61326–2–6 Edition 3.0 2020–10. 

19–44 ......... American National Standard—Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems.ANSI/IEEE C63.24–2021. 

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

6–474 ......... Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities .. ASTM F3352–19. 

H. In Vitro Diagnostics (IVD) 

7–309 ......... Radiological protection—Performance criteria for laboratories using the cytokinesis 

block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological 

dosimetry.

ISO 17099 First edition 2014–11–15. 

7–310 ......... Radiological protection—Performance criteria for service laboratories performing biological dosimetry by cytogenetics.ISO 19238 Second edition 2014–02–01. 

7–311 ......... A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In 

Vitro Medical Laboratory Tests.

CLSI EP39, 1st Edition 

I. Materials 

8–580 ......... Eyewear display—Part 20–10: Fundamental measurement methods—Optical properties.IEC 63145–20–10 Edition 1.0 2019–08. 

8–581 ......... Eyewear display—Part 20–20: Fundamental measurement methods—Image quality .. IEC 63145–20–20 Edition 1.0 2019–09. 

8–582 ......... Eyewear display—Part 22–10: Specific measurement methods for AR type—Optical 

properties.

IEC 63145–22–10 Edition 1.0 2020–01. 

J. Nanotechnology 

18–19 ......... Nanotechnologies—Measurements of particle size and shape distributions by scanning electron microscopy.ISO 19749 First edition 2021–07. 

18–20 ......... Standard Guide for Visualization and Identification of Nanomaterials in Biological and 

Nonbiological Matrices Using Darkfield Microscopy/Hyperspectral Imaging (DFM/ 

HSI) Analysis.

ASTM E3275–21. 

K. Neurology 

No new entries at this time. 

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

No new entries at this time. 

M. Ophthalmic 

No new entries at this time. 

N. Orthopedic 

11–390 ....... Implants for surgery—Pre-clinical mechanical assessment of spinal implants and particular requirements—Part 2: Spinal intervertebral body fusion devices.ISO 23089–2 First edition 2021–05. 

11–391 ....... Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational 

Stops.

ASTM F2722–21. 

11–392 ....... Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing 

Resistance to Dynamic Disassociation.

ASTM F2723–21. 


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Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 24181 

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

Recognition 

No. Title of standard 1 Reference No. and date 

11–393 ....... Standard Test Method for Evaluating Mobile Bearing Knee Dislocation ....................... ASTM F2724–21. 

O. Physical Medicine 

16–232 ....... Medical electrical equipment—Part 2–78: Particular requirements for basic safety and 

essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.

IEC 80601–2–78 Edition 1.0 2019–07. 

P. Radiology 

No new entries at this time. 

Q. Software/Informatics 

13–120 ....... Medical Devices and Medical Systems—Essential safety requirements for equipment 

comprising the patient-centric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model.

ANSI/AAMI 2700–1:2019. 

R. Sterility 

14–571 ....... Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation time for a biological indicator.ISO 11138–8 First edition 2021–07. 

S. Tissue Engineering 

No new entries at this time. 

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 available at https://

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

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

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

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

[OMB No. 0917–0040] 

Request for Public Comment: 30-Day 

Information Collection: Request for 

Reinstatement of Indian Health Service 

Purchased/Referred Care Proof of 

Residency 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments; request for reinstatement. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

Indian Health Service (IHS) invites the 

general public to take this opportunity 

to comment on the reinstatement of the 

information collection, Office of 

Management and Budget (OMB) Control 

Number 0917–0040, titled, Purchased/ 

Referred Care Proof of Residency. The 

IHS is requesting OMB to approve a 

reinstatement of this collection. Notice 

regarding the information collection was 

last published in the Federal Register 

on January 24, 2022, and allowed 60 

days for public comment. The purpose 

of this notice is to announce the IHS’s 

intent to reinstate this collection to 

OMB and to allow 30 days for public 

comment to be submitted directly to 

OMB. A copy of the supporting 

statement is available at 

www.regulations.gov (see Docket ID: 

IHS_FRDOC_0001). 

DATES: Consideration will be given to all 

comments received by May 23, 2022. 

ADDRESSES: Direct Your Comments to 

OMB: Send your comments and 

suggestions regarding the proposed 

information collection contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time to: Office of Management 

and Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

FOR FURTHER INFORMATION CONTACT: To 

request additional information, please 

contact Evonne Bennett, Information 

Collection Clearance Officer at: 

Evonne.Bennett@ihs.gov or 301–443– 

4750. 

SUPPLEMENTARY INFORMATION: This 

previously approved information 

collection project was last published in 

the Federal Register on January 24, 

2022, and allowed 60 days for public 

comment (87 FR 3562). No public 

comment was received in response to 

the notice. This notice announces our 

intent to reinstate this collection, which 

expired March 31, 2022; to submit this 


lotter on DSK11XQN23PROD with NOTICES1