Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26465 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Health care providers (Primary Care 

Physician, Emergency Physician, 

Nurse Practitioner and Physician 

Assistant).

TBI Provider Survey ......................... 600 1 15/60 150 

Focus group screener ...................... 36 1 5/60 3 

Focus group questionnaire .............. 31 1 5/60 3 

Focus group discussion guide ......... 31 1 85/60 44 

Total ........................................... ........................................................... ........................ ........................ ........................ 200 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–12251 Filed 6–6–18; 8:45 am] 

BILLING CODE 4163–18–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: 

049 

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: 049’’ 

(Recognition List Number: 049), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: These modifications to the list of 

recognized standards are applicable 

June 7, 2018. 

ADDRESSES: You may submit comments 

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: 049.’’ 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: 

049. 

• 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 


sradovich on DSK3GMQ082PROD with NOTICES
26466 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

‘‘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: 049 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: 049 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: 049’’ 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. 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 (FDAMA) (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 notice of 

February 25, 1998 (63 FR 9561), FDA 

announced the availability of a guidance 

entitled ‘‘Recognition and Use of 

Consensus Standards.’’ The notice 

described how FDA would implement 

its standard recognition program and 

provided the initial list of recognized 

standards. The guidance was updated in 

September 2007 and is available at 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm077274.htm. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, can be accessed at 

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

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. 

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 program is 

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

MedicalDevices/DeviceRegulationand

Guidance/Standards/default.htm. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 049 

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: 049’’ 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 the 

initial addition of standards not 

previously recognized by FDA. 

TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

A. Anesthesiology 

1–86 .................. ........................ ISO 8185 Third edition 2008–06–15 (Corrected version), Respiratory 

tract humidifiers for medical use—Particular requirements for respiratory humidification systems.

Withdrawn. See 1–138. 

1–95 .................. ........................ ISO 5366–3 Second edition 2001–08–15 Anaesthetic and Respiratory 

Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy 

Tubes [Including TECHNICAL CORRIGENDUM 1 (2003)].

Withdrawn. See 1–117. 

1–107 ................ ........................ ANSI/AAMI/ISO 5356–1:2004 Anaesthetic and respiratory equipment—Conical connectors—Part 1: Cones and sockets.Transferred. See 1–62. 

1–109 ................ ........................ ANSI/AAMI/ISO 5362:2006 Anaesthetic reservoir bags ......................... Transferred. See 1–75. 

1–121 ................ 1–129 ISO 5359 Fourth edition 2014–10–01 Anaesthetic and respiratory 

equipment—Low-pressure hose assemblies for use with medical 

gases [Including AMENDMENT 1 (2017)].

Withdrawn and replaced with 

newer version including amendment. 

1–128 ................ 1–130 ISO 18082 First edition 2014–06–15 Anaesthetic and respiratory 

equipment—Dimensions of noninterchangeable screw-threaded 

(NIST) low-pressure connectors for medical gases [Including 

AMENDMENT 1 (2017)].

Withdrawn and replaced with 

newer version including amendment. 

B. Biocompatibility 

2–118 ................ ........................ ANSI/AAMI/ISO 10993–11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity.Transferred. See 2–176. 

2–120 ................ ........................ ANSI/AAMI/ISO 10993–6:2007/(R)2014 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation.Withdrawn. 

2–153 ................ ........................ ANSI/AAMI/ISO 10993–5:2009/(R)2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity.Transferred. See 2–245. 


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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 

2–156 ................ ........................ ANSI/AAMI/ISO 10993–1:2009/(R)2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.Transferred. See 2–220. 

2–163 ................ ........................ ANSI/AAMI/ISO 10993–9:2009/(R)2014 Biological evaluation of medical devices—Part 9: Framework for identification and quantification 

of potential degradation products.

Transferred. See 2–168. 

2–165 ................ ........................ ANSI/AAMI/ISO 10993–14:2001/(R) 2011 Biological evaluation of 

medical devices—Part 14: Identification and quantification of degradation products form ceramics.

Transferred. See 2–170. 

2–171 ................ 2–249 ISO 10993–16 Third edition 2017–05 Biological evaluation of medical 

devices—Part 16: Toxicokinetic study design for degradation products and leachables.

Withdrawn and replaced with 

newer version. 

2–172 ................ ........................ ANSI/AAMI/TIR 10993–19:2006 Biological evaluation of medical devices—Part 19: Physicochemical, morphological, and topographical 

characterization of materials.

Transferred. See 2–167. 

2–173 ................ ........................ ANSI/AAMI/ISO 10993–10:2010/(R)2014 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization.Transferred. See 2–174. 

2–180 ................ ........................ ANSI/AAMI/ISO 10993–16:2010/(R)2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation 

products and leachables from medical devices.

Withdrawn. 

2–181 ................ ........................ ANSI/AAMI/ISO 14155:2011 Clinical investigation of medical devices 

for human subjects—Good clinical practice [Including: Technical 

Corrigendum 1 (2011)].

Transferred. See 2–205. 

2–190 ................ ........................ ANSI/AAMI/ISO 10993–13:2010/(R)2014 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation 

products from polymeric medical devices.

Transferred. See 2–169. 

2–198 ................ ........................ ANSI/AAMI/ISO 10993–12:2012 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials.Transferred. See 2–191. 

2–207 ................ 2–250 ASTM F756–17 Standard Practice for Assessment of Hemolytic Properties of Materials.Withdrawn and replaced with 

newer version. 

2–221 ................ ........................ ANSI/AAMI/ISO 10993–2:2006 (R2014) Biological evaluation of medical devices—Part 2: Animal welfare requirements.Transferred. See 2–222. 

2–226 ................ ........................ ANSI/AAMI/ISO 10993–3:2014 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.Transferred. See 2–228. 

2–229 ................ 2–251 USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Direct 

Contact Test.

Withdrawn and replaced with 

newer version. 

2–230 ................ 2–252 USP 40–NF35:2017 <87> Biological Reactivity Test, In Vitro—Elution 

Test.

Withdrawn and replaced with 

newer version. 

2–231 ................ 2–253 USP 40–NF35:2017 <88> Biological Reactivity Tests, In Vivo .............. Withdrawn and replaced with 

newer version. 

2–232 ................ 2–254 USP 40–NF35:2017 <151> Pyrogen Test (USP Rabbit Test) ............... Withdrawn and replaced with 

newer version. Extent of Recognition. 

2–234 ................ ........................ ANSI/AAMI/ISO 10993–4:2002/(R) 2013 & A1:2006/(R)2013 Biological 

evaluation of medical devices—Part 4: Selection of tests for interaction with blood [Including AMENDMENT 1 (2006)].

Withdrawn. 

2–236 ................ ........................ ANSI/AAMI/ISO 10993–17:2002(R) 2012 Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable 

substances.

Transferred. See 2–237. 

2–239 ................ ........................ ANSI/AAMI/ISO TIR 10993–20:2006 Biological Evaluation of Medical 

Devices—Part 20: Principles and methods for immunotoxicology 

testing of medical devices.

Transferred. See 2–240. 

2–242 ................ ........................ ANSI/AAMI/ISO TIR 37137:2014 Cardiovascular biological evaluation 

of medical devices—Guidance for absorbable implants.

Transferred. See 2–241. 

C. Cardiovascular 

3–80 .................. ........................ ANSI/AAMI/ISO 81060–1:2007/(R)2013 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for nonautomated measurement type.Transferred. See 3–96. 

3–83 .................. ........................ ANSI/AAMI/ISO 14708–5:2010 Implants for surgery—Active 

implantable medical devices—Part 5: Circulatory support devices.

Transferred. See 3–92. 

3–101 ................ ........................ ANSI/AAMI/IEC 60601–2–27:2011 Medical electrical equipment—Part 

2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.

Transferred. See 3–126. 

3–106 ................ ........................ ANSI/AAMI/IEC 60601–2–25:2011/(R)2016 Medical electrical equipment—Part 2–25: Particular requirements for the basic safety and 

essential performance of electrocardiographs.

Transferred. See 3–105. 


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26468 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

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

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

3–109 ................ ........................ ANSI/AAMI/ISO 27186:2010 Active implantable medical devices— 

Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements.

Transferred. See 3–89. 

3–111 ................ ........................ ANSI/AAMI/ISO 25539–3:2011 Cardiovascular implants— 

Endovascular devices—Part 3: Vena cava filters.

Transferred. See 3–103. 

3–112 ................ ........................ ANSI/AAMI/ISO 7199:2009 Cardiovascular implants and artificial organs—Blood gas exchangers (oxygenators).Transferred. See 3–124. 

3–117 ................ ........................ ANSI/AAMI/ISO 81060–2 Second edition 2013–05–01 Non-invasive 

sphygmomanometers—Part 2: Clinical validation of automated 

measurement type.

Transferred. See 3–122. 

3–120 ................ ........................ ANSI/AAMI/ISO 25539–2:2012 Cardiovascular implants— 

Endovascular devices—Part 2: Vascular stents.

Transferred. See 3–116. 

3–124 ................ 3–150 ISO 7199 Third edition 2016–11–15 Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators).Withdrawn and replaced with 

newer version. 

3–128 ................ ........................ ANSI/AAMI/ISO 14117:2012 Active implantable medical devices— 

Electromagnetic compatibility—EMC test protocols for implantable 

cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.

Transferred. See 3–139. 

3–130 ................ 3–151 ANSI/AAMI/IEC 80601–2–30:2009 & A1:2013/(R2016) Medical electrical equipment—Part 2–30: Particular requirements for the basic 

safety and essential performance of automated non-invasive sphygmomanometers.

Reaffirmation. Extent of Recognition. Transferred. See 3–123. 

3–131 ................ ........................ ANSI/AAMI/ISO 27185:2012 Cardiac rhythm management devices— 

Symbols to be used with cardiac rhythm management device labels, 

and information to be supplied—General requirements.

Transferred. See 3–132. 

3–140 ................ ........................ ANSI/AAMI/ISO 5840–3:2013 Cardiovascular implants—Cardiac valve 

prostheses—Part 3: Heart valve substitutes implanted by 

transcatheter techniques.

Transferred. See 3–133. 

3–141 ................ ........................ ANSI/AAMI/ISO 5841–3:2013 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS–1) for implantable pacemakers.Transferred. See 3–125. 

3–146 ................ ........................ ANSI/AAMI/ISO 5840–1:2015 Cardiovascular implants—Cardiac valve 

prostheses—Part 1: General requirements.

Transferred. See 3–145. 

3–148 ................ ........................ ANSI/AAMI/ISO 5840–2:2015 Cardiovascular implants—Cardiac valve 

prostheses—Part 2: Surgically implanted heart valve substitutes.

Transferred. See 3–147. 

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

4–50 .................. ........................ ADA Specification No. 18: 1992 Alginate Impression Materials ............. Withdrawn. See 4–240. 

4–89 .................. ........................ ANSI/ADA Specification No. 53 Reaffirmed by ANSI: August 2013 

Polymer-Based Crown and Bridge Materials.

Reaffirmation. 

4–91 .................. ........................ ANSI/ADA Standard No. 80/ISO 7491:2000 Reaffirmed by ANSI: May 

2013 Dental Materials—Determination of Color Stability.

Transferred. See 4–241. 

4–119 ................ ........................ ANSI/ADA Specification No. 82:1998/ISO 13716:1999 Reaffirmed by 

ANSI: January 2009 Dental Reversible/Irreversible Hydrocolloid Impression Material Systems.

Withdrawn. See 4–240. 

4–193 ................ ........................ ANSI/ADA Standard No. 15–2008/ISO 22112:2005 Reaffirmed by 

ANSI: May 2013 Artificial Teeth for Dental Prostheses.

Transferred. See 4–151. 

4–230 ................ ........................ ANSI/ADA Standard No. 30/ISO 3107:2011 Approved by ANSI: February 2013 Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol 

Cements.

Transferred. See 4–198. 

4–235 ................ ........................ ANSI/ADA Standard No. 100/ISO 27020:2010 Approved by ANSI: November 2012 Orthodontic Brackets and Tubes.Transferred. See 4–218. 

4–237 ................ ........................ ANSI/ADA Standard No.120–2009/ISO 20127:2005 Reaffirmed by 

ANSI: September 8, 2014 Powered Toothbrushes.

Transferred. See 4–238. 

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

5–65 .................. ........................ ANSI/AAMI/ISO 80369–1:2010 Small bore connectors for liquids and 

gases in healthcare applications—Part 1: General requirements.

Transferred. See 5–63. 

5–70 .................. ........................ ANSI/AAMI/ISO 14971:2007/(R)2010 (Corrected 4 October 2007) 

Medical devices—Application of risk management to medical devices.

Transferred. See 5–40. 

5–92 .................. ........................ ANSI/AAMI/IEC 60601–1–8:2006 and A1:2012 Medical Electrical 

Equipment—Part 1–8: General requirements for basic safety and 

essential performance—Collateral Standard: General requirements, 

tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

Transferred. See 5–76. 

5–96 .................. ........................ ANSI/AAMI/IEC 62366–1:2015 Medical devices—Part 1: Application of 

usability engineering to medical devices.

Transferred. See 5–114. 


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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 

5–100 ................ ........................ ANSI/AAMI/ISO 80369–20:2015 Small-bore connectors for liquids and 

gases in healthcare applications—Part 20: Common test methods.

Transferred. See 5–97. 

5–118 ................ ........................ ANSI/AAMI/ISO 15223–1:2016 Medical devices—Symbols to be used 

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

Transferred. See 5–117. 

5–119 ................ ........................ ANSI/AAMI/ISO 80369–5:2016 Small-bore connectors for liquids and 

gases in healthcare applications—Part 5: Connectors for limb cuff 

inflation applications.

Transferred. See 5–107. 

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

19–2 .................. ........................ ANSI/AAMI/IEC 60601–1–2:2007 (R2012) Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests.Transferred. See 19–1. 

19–12 ................ ........................ ANSI/AAMI/IEC 60601–1–2:2014 Medical electrical equipment—Part 

1–2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests.

Transferred. See 19–8. 

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

6–149 ................ 6–401 ASTM D7160–16 Standard Practice for Determination of Expiration 

Dating for Medical Gloves.

Withdrawn and replaced with 

newer version. 

6–178 ................ ........................ ASTM D6124–06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.Reaffirmation. 

6–214 ................ ........................ ASTM D6355–07 (Reapproved 2017) Standard Test Method for 

Human Repeat Insult Patch Testing of Medical Glove.

Reaffirmation. 

6–217 ................ 6–402 ASTM F1670/F1670M–17 Standard Test Method for Resistance of 

Materials Used in Protective Clothing to Penetration by Synthetic 

Blood.

Withdrawn and replaced with 

newer version. 

6–227 ................ ........................ ANSI/AAMI/IEC 60601–2–21:2009 Medical electrical equipment—Part 

2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers.

Transferred. See 6–388. 

6–229 ................ ........................ ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part 

2–2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment.

Transferred. See 6–389. 

6–232 ................ 6–403 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.

Withdrawn and replaced with 

newer version. 

6–230 ................ ........................ ANSI/AAMI/IEC 60601–2–19:2009 Medical electrical equipment—Part 

2–19: Particular requirements for the basic safety and essential performance of infant incubators.

Transferred. See 6–385. 

6–235 ................ ........................ ANSI/AAMI/IEC 60601–2–50:2009 Medical electrical equipment—Part 

2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment.

Transferred. See 6–387. 

6–270 ................ ........................ ASTM F1840–10 (Reapproved 2016) Standard Terminology for Surgical Suture Needles.Reaffirmation. 

6–304 ................ 6–404 ISO 7886–1 Second edition 2017–05 Sterile hypodermic syringes for 

single use—Part 1: Syringes for manual use.

Withdrawn and replaced with 

newer version. 

6–307 ................ 6–405 IEC 80601–2–59 Edition 2.0 2017–09 Medical electrical equipment— 

Part 2–59: Particular requirements for the basic safety and essential 

performance of screening thermographs for human febrile temperature screening.

Withdrawn and replaced with 

newer version. 

6–323 ................ 6–406 ASTM F1862/F1862M–17 Standard Test Method for Resistance of 

Medical Face Masks to Penetration by Synthetic Blood (Horizontal 

Projection of Fixed Volume at a Known Velocity).

Withdrawn and replaced with 

newer version. 

6–337 ................ ........................ ANSI/AAMI/IEC 60601–2–20:2009 Medical electrical equipment—Part 

2–20: Particular requirements for the basic safety and essential performance of transport incubators [Including AMENDMENT 1 (2016)].

Transferred. See 6–386. 

H. In Vitro Diagnostics (IVD) 

7–271 ................ ........................ CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility Testing.Extent of recognition. 


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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 

I. Materials 

8–113 ................ ........................ ASTM F1147–05 (Reapproved 2017) e1 Standard Test Method for 

Tension Testing of Calcium Phosphate and Metallic Coatings.

Reaffirmation. 

8–337 ................ ........................ ASTM F621–12 (Reapproved 2017) Standard Specification for Stainless Steel Forgings for Surgical Implants.Reaffirmation. 

8–356 ................ ........................ ASTM F67–13 (Reapproved 2017) Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, 

UNS R50400, UNS R50550, UNS R50700).

Reaffirmation. 

8–446 ................ 8–460 ASTM F2848–17 Standard Specification for Medical-Grade Ultra-High 

Molecular Weight Polyethylene Yarns.

Withdrawn and replaced with 

newer version. Extent of recognition. 

J. Nanotechnology 

No new entries at this time 

K. Neurology 

17–1 .................. ........................ ANSI/AAMI NS28:1988/(R)2015 Intracranial pressure monitoring devices.Reaffirmation. Extent of recognition. 

17–8 .................. 17–15 ISO 14708–3 Second edition 2017–04 Implants for surgery—Active 

implantable medical devices—Part 3: Implantable neurostimulators.

Withdrawn and replaced with 

newer version. 

17–10 ................ ........................ ANSI/AAMI/ISO 14708–3:2008/(R)2011 Implants for surgery—Active 

implantable medical devices—Part 3: Implantable neurostimulators.

Withdrawn. 

17–11 ................ 17–16 IEC 60601–2–10 Edition 2.1 2016–04 Medical electrical equipment— 

Part 2–10: Particular requirements for the basic safety and essential 

performance of nerve and muscle stimulators.

Withdrawn and replaced with 

newer version. 

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

9–64 .................. ........................ ANSI/AAMI/IEC 60601–2–2:2009 Medical electrical equipment—Part 

2–2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency 

surgical accessories.

Withdrawn. Duplicate recognition. 

See 6–229. 

9–66 .................. ........................ ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and 

extracorporeal blood circuit for hemodialyzers, hemodiafilters, and 

hemofilters.

Transferred. See 9–89. 

9–81 .................. ........................ ANSI/AAMI/IEC 60601–2–16:2012 Medical electrical equipment—Part 

2–16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment.

Transferred. See 9–80 

9–91 .................. ........................ ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and 

extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters, 

and hemoconcentrators [Including AMENDMENT 1 (2013)].

Transferred. See 9–92. 

9–91 .................. 9–114 IEC 60601–2–18: Edition 3.0 2009–08, medical electrical equipment— 

part 2–18: particular requirements for the basic safety and essential 

performance of endoscopic equipment.

Withdrawn and replaced with new 

recognition number. 

9–93 .................. 9–115 ISO 25841 Third edition 2017–08 Female condoms—Requirements 

and test methods.

Withdrawn and replaced with 

newer version. 

9–103 ................ ........................ ANSI/AAMI/ISO 26722:2014 Water treatment equipment for 

haemodialysis applications and related therapies.

Transferred. See 9–101. 

9–104 ................ ........................ ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapies.Transferred. See 9–97. 

9–105 ................ ........................ ANSI/AAMI/ISO 13959:2014 Water for hemodialysis and related therapies.Transferred. See 9–98. 

9–106 ................ ........................ ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis 

and related therapies.

Transferred. See 9–100. 

9–107 ................ ........................ ANSI/AAMI/ISO 23500:2014 Guidance for the preparation and quality 

management of fluids for hemodialysis and related therapies.

Transferred. See 9–99. 

M. Ophthalmic 

10–43 ................ 10–105 ISO 11979–8 Third edition 2017–04 Ophthalmic Implants—Intraocular 

lenses—Part 8: Fundamental requirements.

Withdrawn and replaced with 

newer version. 

10–46 ................ 10–106 ISO 18369–3 Second edition 2017–08 Ophthalmic optics—Contact 

lenses—Part 3: Measurement methods.

Withdrawn and replaced with 

newer version. 

10–54 ................ 10–107 ISO 18369–4 Second edition 2017–08 Ophthalmic optics—Contact 

lenses—Part 4: Physicochemical properties of contact lens materials.

Withdrawn and replaced with 

newer version. 

10–80 ................ 10–108 ISO 18369–2 Third edition 2017–08 Ophthalmic optics—Contact 

lenses—Part 2: Tolerances.

Withdrawn and replaced with 

newer version. 


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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26471 

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

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

10–83 ................ 10–109 ISO 18369–1 Second edition 2017–08 Ophthalmic optics—Contact 

lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications.

Withdrawn and replaced with 

newer version. 

N. Orthopedic 

11–259 .............. ........................ ASTM F2887—12 Standard Specification for Total Elbow Prostheses .. Withdrawn. See 11–321. 

O. Physical Medicine 

16–200 .............. 16–201 ISO 7176–19 Second edition 2008–07–15 AMENDMENT 1 2015–11– 

15. Wheelchairs—Part 19: Wheeled mobility devices for use as 

seats in motor vehicles [Including AMENDMENT 1 (2015)].

Withdrawn and replaced with a 

newer version including amendment. 

P. Radiology 

12–139 .............. ........................ NEMA UD 2–2004 (R2009) Acoustic Output Measurement Standard 

for Diagnostic Ultrasound Equipment, Revision 3.

Withdrawn. Duplicate recognition. 

See 12–105. 

12–202 .............. 12–308 IEC 60601–2–43 Edition 2.1 2017–05 CONSOLIDATED VERSION 

Medical electrical equipment—Part 2–43: Particular requirements for 

the safety and essential performance of X-Ray Equipment for interventional procedures.

Withdrawn and replaced with 

newer version. 

12–204 .............. 12–309 IEC 60601–2–28 Edition 3.0 2017–06 Medical electrical equipment— 

Part 2–28: Particular requirements for the basic safety and essential 

performance of X-ray tube assemblies for medical diagnosis.

Withdrawn and replaced with 

newer version. 

12–251 .............. 12–310 IEC 60601–2–63 Edition 1.1 2017–07 CONSOLIDATED VERSION 

Medical electrical equipment—Part 2–63: Particular requirements for 

the basic safety and essential performance of dental extra-oral XRay equipment.

Withdrawn and replaced with 

newer version. 

12–252 .............. 12–311 IEC 60601–2–65 Edition 1.1 2017–05 CONSOLIDATED VERSION 

Medical electrical equipment—Part 2–65: Particular requirements for 

the basic safety and essential performance of dental intra-oral XRay equipment.

Withdrawn and replaced with 

newer version. 

12–227 .............. 12–312 IEC 61391–1 Edition 1.1 2017–07 CONSOLIDATED VERSION 

Ultrasonics—Pulse-echo scanners—Part 1: Techniques for calibrating spatial measurement systems and measurement of system 

point-spread function response.

Withdrawn and replaced with 

newer version. 

12–276 .............. 12–313 IEC TS 62462 Edition 2.0 2017–07 Ultrasonics—Output test—Guidance for the maintenance of ultrasound physiotherapy systems.Withdrawn and replaced with 

newer version. 

12–155 .............. 12–314 ISO 11554 Fourth edition 2017–07 Optics and photonics—Lasers and 

laser-related equipment—Test methods for laser beam power, energy and temporal characteristics.

Withdrawn and replaced with 

newer version. 

12–192 .............. 12–315 NEMA Standards Publication MS 8–2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems.Withdrawn and replaced with 

newer version. 

12–258 .............. 12–316 IEC 62359 Edition 2.1 2017–09 CONSOLIDATED VERSION 

Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

Withdrawn and replaced with 

newer version. 

Q. Software/Informatics 

13–39 ................ ........................ ANSI/AAMI/IEC 80001–1:2010 Application of risk management for IT 

Networks incorporating medical devices—Part 1: Roles, responsibilities and activities.

Transferred. See 13–38. 

13–41 ................ ........................ ANSI/AAMI/IEC TIR80001–2–1:2012 Application of risk management 

for IT-networks incorporating medical devices—Part 2–1: Step by 

step risk management of medical IT-networks; Practical applications 

and examples.

Transferred. See 13–40. 

13–43 ................ ........................ ANSI/AAMI/IEC TIR80001–2–2:2012 Technical Information Report Application of risk management for IT-networks incorporating medical 

devices—Part 2–2: Guidance for the disclosure and communication 

of medical device security needs, risks and controls.

Transferred. See 13–42. 

13–45 ................ ........................ ANSI/AAMI/IEC TIR80001–2–3:2012 Technical Information Report Application of risk management for IT-networks incorporating medical 

devices—Part 2–3: Guidance for wireless networks.

Transferred. See 13–44. 


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26472 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

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

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

13–64 ................ ........................ ANSI/AAMI/IEC TIR80001–2–4:2012 Technical Information Report Application of risk management for IT-networks incorporating medical 

devices—Part 2–4: General implementation guidance for healthcare 

delivery organizations.

Transferred. See 13–63. 

R. Sterility 

14–221 .............. ........................ ANSI/AAMI/ISO TIR 11139:2006 Sterilization of health care products— 

Vocabulary.

Transferred. See 14–325. 

14–222 .............. ........................ ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipment.Transferred. See 14–354. 

14–227 .............. ........................ ANSI/AAMI/ISO 11737–1:2006 (R)2011 Sterilization of health care 

products—Microbiological methods—Part 1: Determination of the 

population of microorganisms on product.

Transferred. See 14–407. 

14–238 .............. ........................ ANSI/AAMI/ISO 11140–5:2007/(R)2012 Sterilization of health care 

products—Chemical indicators—Part 5: Class 2 indicators for Bowie 

and Dick air removal test sheets and packs.

Transferred. See 14–332. 

14–261 .............. ........................ ANSI/AAMI/ISO 17665–1:2006/(R)2013 Sterilization of health care 

products—Moist heat—Part 1: Requirements for the development, 

validation, and routine control of a sterilization process for medical 

devices.

Transferred. See 14–333. 

14–274 .............. ........................ ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results.Transferred. See 14–334. 

14–278 .............. ........................ ANSI/AAMI/ISO 10993–7:2008(R)2012 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals.Transferred. See 14–408. 

14–285 .............. ........................ ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results.Transferred. See 14–336. 

14–287 .............. ........................ ANSI/AAMI/ISO 11737–2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed 

in the definition, validation and maintenance of a sterilization process.

Transferred. See 14–327. 

14–291 .............. ........................ ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of health care products—General requirements for characterization of a sterilizing 

agent and the development, validation and routine control of a sterilization process for medical devices.

Transferred. See 14–337. 

14–295 .............. ........................ ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of 

resterilizable medical devices.

Reaffirmation. 

14–298 .............. ........................ ANSI/AAMI/ISO 11137–3:2006/(R)2010 Sterilization of health care 

products—Radiation—Part 3: Guidance on dosimetric aspects.

Withdrawn. See 14–510. 

14–330 .............. 14–510 ISO 11137–3 Second edition 2017–06 Sterilization of health care 

products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control.

Withdrawn and replaced with 

newer version. 

14–339 .............. ........................ ANSI/AAMI/ISO 20857:2010/(R)2015 Sterilization of health care products—Dry heat—Requirements for the development, validation and 

routine control of a sterilization process for medical devices.

Transferred. See 14–340. 

14–348 .............. ........................ ANSI/AAMI/ISO 13408–2:2003/(R)2013 Aseptic processing of health 

care products—Part 2: Filtration.

Transferred. See 14–138. 

14–349 .............. ........................ ANSI/AAMI/ISO 13408–3:2006/(R)2015 Aseptic processing of health 

care products—Part 3: Lyophilization.

Transferred. See 14–239. 

14–350 .............. ........................ ANSI/AAMI/ISO 13408–4:2005/(R)2014 Aseptic processing of health 

care products—Part 4: Clean-in-place technologies.

Transferred. See 14–191. 

14–351 .............. ........................ ANSI/AAMI/ISO 13408–5:2006/(R)2015 Aseptic processing of health 

care products—Part 5: Sterilization in place.

Transferred. See 14–240. 

14–358 .............. ........................ ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for 

characterization, development, validation and routine control of a 

sterilization process for medical devices.

Transferred. See 14–361. 

14–376 .............. ........................ ANSI/AAMI/ISO TIR 17665–2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/ 

AAMI/ISO 17665–1.

Transferred. See 14–277. 

14–387 .............. ........................ ANSI/AAMI/ISO 13408–7:2012 Aseptic processing of health care products—Part 7: Alternative processes for medical devices and combination products.Transferred. See 14–388. 

14–425 .............. ........................ ANSI/AAMI/ISO 13408–6:2005/(R) 2013 & A1:2013 Aseptic processing of health care products—Part 6: Isolator systems [Including 

AMENDMENT1 (2013)].

Transferred. See 14–424. 


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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26473 

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

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

14–426 .............. ........................ ANSI/AAMI/ISO 13408–1:2008 (R2011) Aseptic processing of health 

care products—Part 1: General requirements [Including 

AMENDMENT1 (2013)].

Transferred. See 14–427. 

14–438 .............. ........................ ANSI/AAMI/ISO 11137–2:2013 Sterilization of health care products— 

Radiation—Part 2: Establishing the sterilization dose.

Transferred. See 14–409. 

14–439 .............. 14–511 ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization 

and sterility assurance in health care facilities.

Withdrawn and replaced with 

newer version. 

14–457 .............. ........................ ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile 

barrier systems and packaging [Including AMENDMENT 1 (2013)].

Transferred. See 14–454. 

14–458 .............. ........................ ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, 

sealing and assembly processes [Including AMENDMENT 1 (2013)].

Transferred. See 14–455. 

14–459 .............. ........................ ANSI/AAMI/ISO 11140–1:2014 Sterilization of health care products— 

Chemical indicators—Part 1: General requirements.

Transferred. See 14–460. 

14–461 .............. ........................ ANSI/AAMI/ISO 11137–1:2006/(R)2010 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)].

Transferred. See 14–428. 

14–479 .............. ........................ ANSI/AAMI/ISO 11135:2014 Sterilization of health care products— 

Ethylene oxide—Requirements for development, validation and routine control of a sterilization process for medical devices.

Transferred. See 14–452. 

S. Tissue Engineering 

15–17 ................ ........................ ASTM F2311–08 Standard Guide for Classification of Therapeutic Skin 

Substitutes.

Withdrawn. 

15–23 ................ ........................ ASTM F2739–08 Standard Guide for Quantitating Cell Viability within 

Biomaterial Scaffolds.

Withdrawn. See 15–50. 

15–37 ................ 15–51 ASTM F2347–15 Standard Guide for Characterization and Testing of 

Hyaluronan as Starting Materials Intended for Use in Biomedical 

and Tissue Engineered Medical Product Applications.

Withdrawn and replaced with 

newer version. 

15–42 ................ 15–52 ASTM F2064–17 Standard Guide for Characterization and Testing of 

Alginates as Starting Materials Intended for Use in Biomedical and 

Tissue Engineered Medical Product Applications.

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: 049. 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

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

A. Anesthesiology 

1–131 ................. Medical suction equipment—Part 1: Electrically powered suction equipment .......................... ISO 10079–1 Third Edition 

2015–11–01. 

1–132 ................. Medical suction equipment—Part 2: Manually powered suction equipment ............................ ISO 10079–2 Third Edition 

2014–05–01. 

1–133 ................. Medical suction equipment—Part 3: Suction equipment powered from a vacuum or positive 

pressure gas source.

ISO 10079–3 Third Edition 

2014–05–01. 

1–134 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1: 

Evaluation and testing within a risk management process.

ISO 18562–1 First edition 

2017–03. 

1–135 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 2: 

Tests for emissions of particulate matter.

ISO 18562–2 First edition 

2017–03. 

1–136 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 3: 

Tests for emissions of volatile organic compounds.

ISO 18562–3 First edition 

2017–03. 

1–137 ................. Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 4: 

Tests for leachables in condensate.

ISO 18562–4 First edition 

2017–03. 

1–138 ................. Medical electrical equipment—Part 2–74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.ISO 80601–2–74 First edition 

2017–05. 


sradovich on DSK3GMQ082PROD with NOTICES
26474 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 

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

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

B. Biocompatibility 

No new entries at this time 

C. Cardiovascular 

No new entries at this time 

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

4–240 ................. Dentistry—Hydrocolloid impression materials ........................................................................... ISO 21563 First edition 2013– 

08–15. 

4–241 ................. Dental materials—Determination of colour stability .................................................................. ISO 7491 Second edition 

2000–09–01. 

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

No new entries at this time 

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

No new entries at this time 

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

6–407 ................. Standard Specification for Adult Portable Bed Rails and Related Products ............................ ASTM F3186–17. 

H. In Vitro Diagnostics (IVD) 

7–274 ................. Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline ................. CLSI MM17–A Vol. 28 No. 9 

(Replaces MM17–P Vol. 27 

No. 21). 

I. Materials 

8–461 ................. Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable 

Medical Devices.

ASTM F3208–17. 

8–462 ................. Standard Test Method for Determining the Flexural Stiffness of Medical Textiles .................. ASTM F3260–17. 

8–463 ................. Standard Guide for Additive Manufacturing—General Principles—Requirements for Purchased AM Parts.ISO/ASTM 52901 First edition 

2017–08. 

8–464 ................. Assessment of the safety of magnetic resonance imaging for patients with an active 

implantable medical device.

ISO 10974 Second edition 

2018. 

J. Nanotechnology 

18–9 ................... Nanotechnologies—Guidance on physico-chemical characterization of engineered 

nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)].

ISO/TR 13014 First edition 

2012–05–15. 

18–10 ................. Nanotechnologies—Endotoxin test on nanomaterial samples for in vitro systems—Limulus 

amebocyte lysate (LAL) test.

ISO 29701 First edition 2010– 

09–15. 

K. Neurology 

No new entries at this time 

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

9–115 ................. Condoms—Guidance on clinical studies—Part 1: Male condoms, clinical function studies 

based on self-reports.

ISO 29943–1 First edition 

2017–07. 

9–116 ................. Condoms—Guidance on clinical studies—Part 2: Female condoms, clinical function studies 

based on self-reports.

ISO 29943–2 First edition 

2017–07. 

M. Ophthalmic 

10–110 ............... Ophthalmic implants—Ophthalmic viscosurgical devices [Including AMENDMENT 1 (2017)] ISO 15798 Third edition 

2013–09–15 AMENDMENT 

1 2017–05. 

N. Orthopedic 

No new entries at this time 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26475 

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

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

O. Physical Medicine 

16–202 ............... RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation ...................... RESNA WC–4:2017. 

P. Radiology 

No new entries at this time 

Q. Software/Informatics 

13–104 ............... Software Cybersecurity for Network-Connectable Products, Part 2–1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems.ANSI/UL 2900–2–1, First Edition September 1, 2017. 

R. Sterility 

No new entries at this time 

S. Tissue Engineering 

15–53 ................. Standard Guide for Assessing Medical Device Cytocompatibility with Delivered Cellular 

Therapies.

ASTM F3206 –17. 

15–54 ................. Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model.ASTM F3207–17. 

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. FDA 

will be incorporating the modifications 

and revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will be announcing 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. 

Beginning with recognition list 049, 

FDA will no longer include in the 

database the CDRH Office and Division 

associated with recognized standards, 

Devices Affected, and Processes 

Affected. Beginning with recognition 

list 049 FDA will automatically 

incorporate, upon publication, a U.S. 

parallel adoption of an existing 

recognized international standard. 

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/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123739.htm. 

Dated: May 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12222 Filed 6–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1635] 

Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Prescription Drug User Fee Act 

Waivers for Fixed-Combination 

Antiretroviral Drugs for the President’s 

Emergency Plan for AIDS Relief.’’ This 

draft guidance describes circumstances 

under which an applicant may be 

eligible for a barrier-to-innovation 

waiver for some new drug applications 

(NDAs) for fixed-combination versions 

and single-entity versions of previously 

approved antiretroviral therapies for the 

treatment of human immunodeficiency 

virus (HIV). 

DATES: Submit either electronic or 

written comments on the guidance 

August 6, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


sradovich on DSK3GMQ082PROD with NOTICES