Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39591 

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: 

047 

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: 047’’ 

(Recognition List Number: 047), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit electronic or written 

comments concerning this document at 

any time. These modifications to the list 

of recognized standards are effective 

August 21, 2017. 

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: 047.’’ 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: 

047. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

An electronic copy of Recognition List 

Number: 047 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: 047 

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: 047’’ to Scott 

Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5514, Silver Spring, 

MD 20993, 301–796–6287. Send one 

self-addressed adhesive label to assist 

that office in processing your request, or 

fax your request to 301–847–8144. 

FOR FURTHER INFORMATION CONTACT: 

Scott Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5514, Silver Spring, 

MD 20993, 301–796–6287, 

CDRHStandardsStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39592 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

standards. The guidance was updated in 

September 2007 and is available at 

https://www.fda.gov/downloads/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm077295.pdf. 

Modifications to the initial list of 

recognized standards 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/ 

DeviceRegulationandGuidance/ 

Standards/default.htm. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 047 

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: 047’’ 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 

No new entries at this time. 

B. Biocompatibility 

2–114 .............. 2–246 ASTM F1877—16 Standard Practice for Characterization of 

Particles.

Withdrawn and replaced with newer 

version. 

2–155 .............. ........................ ASTM F2147—01 (Reapproved 2016) Standard Practice for 

Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens.

Reaffirmation. 

2–177 .............. 2–247 ISO 10993–6 Third edition 2016–12–01 Biological evaluation 

of medical devices—Part 6: Tests for local effects after implantation.

Withdrawn and replaced with newer 

version. 

2–235 .............. 2–248 ISO 10993–4 Third edition 2017–04 Biological evaluation of 

medical devices—Part 4: Selection of tests for interactions 

with blood.

Withdrawn and replaced with newer 

version. Extent of recognition. 

C. Cardiovascular 

3–121 .............. 3–149 ISO 25539–1 Second edition 2017–02 Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses.Withdrawn and replaced with newer 

version. 

3–142 .............. ........................ ISO/TS 17137 First edition 2014–05–15 Cardiovascular implants and extracorporeal systems—Cardiovascular absorbable implants.Extent of recognition. 

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

4–96 ................ 4–230 ANSI/ADA Standard No. 30–2013/ISO 3107 Dental Zinc 

Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements.

Withdrawn and replaced with newer 

version. Extent of recognition. 

4–193 .............. ........................ ANSI/ADA Standard No. 15–2008 (R2013)/ISO 22112 Artificial 

Teeth for Dental Prostheses.

Extent of recognition. 

4–215 .............. ........................ ANSI/ADA Standard No. 96–2012 Dental Water-based Cements.Extent of recognition. 

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

5–90 ................ 5–117 ISO 15223–1 Third edition 2016–11–01 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. 

5–91 ................ 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.

Withdrawn and replaced with newer 

version. 

5–107 .............. ........................ IEC 80369–5: Edition 1.0 2016–03 Small-bore connectors for 

liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications [Including CORRIGENDUM 1 (2017)].

Technical corrigendum added. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39593 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

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

No new entries at this time.

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

6–70 ................ ........................ ASTM E825–98 (Reapproved 2016) Standard Specification for 

Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature.

Reaffirmation. 

6–124 .............. ........................ ASTM E1104–98 (Reapproved 2016) Standard Specification 

for Clinical Thermometer Probe Covers and Sheaths.

Reaffirmation 

6–125 .............. ........................ ASTM E1965–98 (Reapproved 2016) Standard Specification 

for Infrared Thermometers for Intermittent Determination of 

Patient Temperature.

Reaffirmation. 

6–297 .............. 6–384 ISO 1135–4 Sixth edition 2015–12–01 Transfusion equipment 

for medical use-Part 4: Transfusion sets for single use, gravity 

feed.

Withdrawn and replaced with newer 

version. 

6–319 .............. 6–385 IEC 60601–2–19 Edition 2.1 2016–04 CONSOLIDATED 

VERSION Medical electrical equipment—Part 2–19: Particular 

requirements for the basic safety and essential performance 

of infant incubators [Including AMENDMENT 1 (2016)].

Withdrawn and replaced with newer 

version including amendment. 

6–320 .............. 6–386 IEC 60601–2–20 Edition 2.1 2016–04 CONSOLIDATED 

VERSION Medical electrical equipment—Part 2–20: Particular 

requirements for the basic safety and essential performance 

of infant transport incubators [Including AMENDMENT 1 

(2016)].

Withdrawn and replaced with newer 

version including amendment. 

6–324 .............. 6–387 IEC 60601–2–50 Edition 2.1 2016–04 CONSOLIDATED 

VERSION Medical electrical equipment—Part 2–50: Particular 

requirements for the basic safety and essential performance 

of infant phototherapy equipment [Including AMENDMENT 1 

(2016)].

Withdrawn and replaced with newer 

version including amendment. 

6–325 .............. 6–388 IEC 60601–2–21 Edition 2.1 2016–04 CONSOLIDATED 

VERSION Medical electrical equipment—Part 2–21: Particular 

requirements for the basic safety and essential performance 

of infant radiant warmers [Including AMENDMENT 1 (2016)].

Withdrawn and replaced with newer 

version including amendment. 

6–336 .............. 6–389 IEC 60601–2–2 Edition 6.0 2017–03 Medical electrical equipment—Part 2–2: Particular requirements for the basic safety 

and essential performance of high frequency surgical equipment and high frequency surgical accessories.

Withdrawn and replaced with newer 

version. 

6–342 .............. 6–390 IEC 80601–2–35 Edition 2.1 2016–04 CONSOLIDATED 

VERSION Medical electrical equipment—Part 2–35: Particular 

requirements for the basic safety and essential performance 

of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including AMENDMENT 1 

(2016)].

Withdrawn and replaced with newer 

version including amendment. 

6–367 .............. 6–391 USP 40–NF35:2017, Sodium Chloride Irrigation .......................... Withdrawn and replaced with newer 

version. 

6–368 .............. 6–392 USP 40–NF35:2017, Sodium Chloride Injection .......................... Withdrawn and replaced with newer

version. 

6–369 .............. 6–393 USP 40–NF35:2017, Nonabsorbable Surgical Suture ................. Withdrawn and replaced with newer 

version. 

6–370 .............. 6–394 USP 40–NF35:2017, <881> Tensile Strength .............................. Withdrawn and replaced with newer 

version. 

6–371 .............. 6–395 USP 40–NF35:2017, <861> Sutures—Diameter .......................... Withdrawn and replaced with newer 

version. 

6–372 .............. 6–396 USP 40–NF35:2017, <871> Sutures—Needle Attachment .......... Withdrawn and replaced with newer 

version. 

6–373 .............. 6–397 USP 40–NF35:2017, Sterile Water for Irrigation .......................... Withdrawn and replaced with newer 

version. 

6–374 .............. 6–398 USP 40–NF35:2017, Heparin Lock Flush Solution ...................... Withdrawn and replaced with newer 

version. 

6–375 .............. 6–399 USP 40–NF35:2017, Absorbable Surgical Suture ........................ Withdrawn and replaced with newer 

version. 

H. In Vitro Diagnostics (IVD) 

7–206 .............. 7–270 I/LA–20 3rd Edition Analytical Performance Characteristics, 

Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities.

Withdrawn and replaced with newer 

version. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39594 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

7–263 .............. 7–271 CLSI M100 27th Edition Performance Standards for Antimicrobial Susceptibility Testing.Withdrawn and replaced with newer 

version. 

I. Materials 

8–58 ................ 8–447 ISO 5832–3 Fourth edition 2016–10–15 Implants for surgery— 

Metallic materials—Part 3: Wrought titanium 6-aluminium 4- 

vanadium alloy.

Withdrawn and replaced with newer 

version. Extent of recognition. 

8–125 .............. 8–448 ASTM F2004–16 Standard Test Method for Transformation 

Temperature of Nickel-Titanium Alloys by Thermal Analysis.

Withdrawn and replaced with newer 

version. 

8–165 .............. 8–449 ASTM F1058–16 Standard Specification for Wrought 

40Cobalt-20 Chromium-16Iron-15Nickel-7Molybdenum Alloy 

Wire, Strip, and Strip Bar for Surgical Implant Applications 

(UNS R30003 and UNS R30008).

Withdrawn and replaced with newer 

version. 

8–185 .............. 8–450 ASTM F451–16 Standard Specification for Acrylic Bone Cement.Withdrawn and replaced with newer 

version. 

8–187 .............. ........................ ISO 13779–1:2008 Second edition 2008–10–01 Implants for 

surgery—Hydroxyapatite—Part 1: Ceramic hydroxyapatite.

Withdrawn. 

8–195 .............. ........................ ASTM F2024–10 (Reapproved 2016) Standard Practice for Xray Diffraction Determination of Phase Content of PlasmaSprayed Hydroxyapatite Coatings.Reaffirmation. 

8–201 .............. 8–451 ASTM F2214–16 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE).Withdrawn and replaced with newer 

version. 

8–202 .............. ........................ ASTM F2183–02 (Reapproved 2008) Standard Test Method for 

Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants (Withdrawn 2017).

Withdrawn. 

8–205 .............. 8–452 ASTM F1635–16 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and 

Fabricated Forms for Surgical Implants.

Withdrawn and replaced with newer 

version. 

8–216 .............. 8–453 ASTM F1295–16 Standard Specification for Wrought Titanium6 Aluminum-7Niobium Alloy for Surgical Implant Applications 

(UNS R56700).

Withdrawn and replaced with newer 

version. 

8–226 .............. ........................ ASTM F603–12 (Reapproved 2016) Standard Specification for 

High-Purity Dense Aluminum Oxide for Medical Application.

Reaffirmation. 

8–333 .............. ........................ ASTM F2393–12 (Reapproved 2016) Standard Specification for 

High-Purity Dense Magnesia Partially Stabilized Zirconia (MgPSZ) for Surgical Implant Applications.

Reaffirmation. 

8–396 .............. 8–454 ASTM F2129–17 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the 

Corrosion Susceptibility of Small Implant Devices.

Withdrawn and replaced with newer 

version. 

8–428 .............. ........................ ASTM F1581–08 (Reapproved 2016) Standard Specification for 

Composition of Anorganic Bone for Surgical Implants.

Reaffirmation. 

8–410 .............. 8–455 ASTM F2902–16 Standard Guide for Assessment of Absorbable Polymeric Implants.Withdrawn and replaced with newer 

version. 

J. Nanotechnology 

No new entries at this time. 

K. Neurology 

No new entries at this time. 

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

No new entries at this time. 

M. Ophthalmic 

10–69 .............. 10–103 ANSI Z80.18–2016 American National Standard for 

Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications, and Test Methodology.

Withdrawn and replaced with newer 

version. 

10–92 .............. 10–104 ANSI Z80.20–2016 American National Standard for 

Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties.

Withdrawn and replaced with newer 

version. 

N. Orthopedic 

11–175 ............ ........................ ASTM F1582–98 (Reapproved 2016) Standard Terminology Relating to Spinal Implants.Reaffirmation. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39595 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

11–242 ............ ........................ ASTM F1839–08 (Reapproved 2016) Standard Specification for 

Rigid Polyurethane Foam for Use as a Standard Material for 

Testing Orthopaedic Devices and Instruments.

Reaffirmation. 

11–269 ............ ........................ ASTM F2423–11 (Reapproved 2016) Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses.Reaffirmation. 

11–280 ............ ........................ ASTM F2624–12 (Reapproved 2016) Standard Test Method for 

Static, Dynamic, and Wear Assessment of Extra-Discal Single 

Level Spinal Constructs.

Reaffirmation. 

11–309 ............ ........................ ASTM F116–12 (Reapproved 2016) Standard Specification for 

Medical Screwdriver Bits.

Reaffirmation. 

O. Physical Medicine 

No new entries at this time. 

P. Radiology 

12–234 ............ 12–306 NEMA MS 12–2016 Quantification and Mapping of Geometric 

Distortion for Special Applications.

Withdrawn and replaced with newer 

version. 

Q. Software/Informatics 

13–66 .............. 13–88 ISO/IEEE 11073–10417 Third edition 2017–04 Health 

informatics—Personal health device communication—Part 

10417: Device specialization—Glucose meter.

Withdrawn and replaced with newer 

version. 

13–67 .............. ........................ ISO/IEEE 11073–10418 First edition 2014–03–01 Health 

informatics—Personal health device communication—Part 

10418: Device specialization: International Normalized Ratio 

(INR) monitor [including TECHNICAL CORRIGENDUM 1 

(2016)].

Technical Corrigendum added. 

R. Sterility 

14–288 ............ 14–501 ASTM F1886/F1886M–16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.Withdrawn and replaced with newer 

version. 

14–338 ............ 14–502 ISO 11138–1 Third edition 2017–03 Sterilization of health care 

products—Biological indicators—Part 1: General requirements.

Withdrawn and replaced with newer 

version. 

14–358 ............ ........................ ANSI/AAMI/ISO 14160:2011/(R)2016 Sterilization of health 

care products—Liquid chemical sterilizing agents for singleuse medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical 

devices.

Reaffirmation. Extent of recognition. 

14–361 ............ ........................ ISO 14160 Second edition 2011–07–01 Sterilization of health 

care products—Liquid chemical sterilizing agents for singleuse medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical 

devices.

Extent of recognition. 

14–485 ............ 14–503 USP 40–NF35:2017, <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.Withdrawn and replaced with newer 

version. 

14–486 ............ 14–504 USP 40–NF35:2017, <71> Sterility Tests ..................................... Withdrawn and replaced with newer 

version. 

14–487 ............ 14–505 USP 40–NF35:2017, <85> Bacterial Endotoxins Test ................. Withdrawn and replaced with newer 

version. 

14–488 ............ 14–506 USP 40–NF35:2017, <161> Medical Devices-Bacterial 

Endotoxin and Pyrogen Tests.

Withdrawn and replaced with newer 

version. 

14–493 ............ 14–507 USP 40–NF35:2017, <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.Withdrawn and replaced with newer 

version. 

14–494 ............ 14–508 USP 40–NF35:2017, <55> Biological Indicators—Resistance 

Performance Tests.

Withdrawn and replaced with newer 

version. 

14–495 ............ 14–509 USP 40–NF35:2017, <1229.5> Biological Indicators for Sterilization.Withdrawn and replaced with newer 

version. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39596 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

S. Tissue Engineering 

15–20 .............. 15–49 ASTM F2027–16 Standard Guide for Characterization and 

Testing of Raw or Starting Materials for Tissue-Engineered 

Medical Products.

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: 047. 

TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

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

A. Anesthesiology 

1–121 ................................... Anaesthetic and respiratory equipment—Low-pressure hose assemblies for use 

with medical gases.

ISO 5359 Fourth edition 2014–10–01. 

1–122 ................................... Anaesthetic and respiratory equipment—Oropharyngeal airways ........................ ISO 5364 Fifth edition 2016–09–01. 

1–123 ................................... Anaesthetic and respiratory equipment—Laryngoscopes for tracheal intubation ISO 7376 Second edition 2009–08–15. 

1–124 ................................... Inhalational anaesthesia systems—Part 7: Anaesthetic systems for use in 

areas with limited logistical supplies of electricity and anaesthetic gases.

ISO 8835–7 First edition 2011–11–01. 

1–125 ................................... Suction catheters for use in the respiratory tract .................................................. ISO 8836 Fourth edition 2014–10–15. 

1–126 ................................... Anaesthetic and respiratory equipment—Supralaryngeal airways and connectors.ISO 11712 First edition 2009–05–15. 

1–127 ................................... Tracheobronchial tubes—Sizing and marking ...................................................... ISO 16628 First edition 2008–11–15. 

1–128 ................................... Anaesthetic and respiratory equipment—Dimensions of noninterchangeable 

screw-threaded (NIST) low-pressure connectors for medical gases.

ISO 18082 First edition 2014–06–15. 

B. Biocompatibility 

No new entries at this time. 

C. Cardiovascular 

No new entries at this time. 

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

4–231 ................................... Dentistry—Testing of adhesion to tooth structure ................................................ ISO/TS 11405 Third edition 2015–02–01. 

4–232 ................................... Dentistry—Base polymers—Part 1: Denture base polymers ................................ ISO 20795–1 Second edition 2013–03–01. 

4–233 ................................... Dentistry—Base polymers—Part 2: Orthodontic base polymers .......................... ISO 20795–2 Second edition 2013–03–01. 

4–234 ................................... Dental Base Polymers ........................................................................................... ANSI/ADA Standard No.139–2012. 

4–235 ................................... Orthodontic Brackets and Tubes .......................................................................... ANSI/ADA Standard No.100–2012/ISO 27020. 

4–236 ................................... Manual Toothbrushes ............................................................................................ ANSI/ADA Standard No.119–2015. 

4–237 ................................... Powered Toothbrushes ......................................................................................... ANSI/ADA Standard No.120–2009 (R2014)/ISO 

20127. 

4–238 ................................... Dentistry—Powered toothbrushes—General requirements and test methods ..... ISO 20127 First edition 2005–03–15. 

4–239 ................................... Cochlear Implant Systems: Requirements for Safety, Functional Verification, 

Labeling and Reliability Reporting.

ANSI/AAMI CI 86:2017. 

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

5–119 ................................... Small-bore connectors for liquids and gases in healthcare applications—Part 5: 

Connectors for limb cuff inflation applications.

ANSI/AAMI/ISO 80369–5: 2016. 

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

19–22 ................................... Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.AAMI TIR69: 2017. 

19–23 ................................... Primary batteries—Part 4: Safety of lithium batteries ........................................... IEC 60086–4 Edition 4.0 2014–09. 

19–24 ................................... Primary batteries—Part 5: Safety of batteries with aqueous electrolyte .............. IEC 60086–5 Edition 4.0 2016–07. 

19–25 ................................... Safety requirements for secondary batteries and battery installations—Part 1: 

General safety information.

IEC 62485–1 Edition 1.0 2015–04. 

19–26 ................................... Safety requirements for secondary batteries and battery installations—Part 2: 

Stationary batteries.

IEC 62485–2 Edition 1.0 2010–06. 

19–27 ................................... Safety requirements for secondary batteries and battery installations—Part 3: 

Traction batteries.

IEC 62485–3 Edition 2.0 2014–07. 

19–28 ................................... Safety requirements for secondary batteries and battery installations—Part 4: 

Valve-regulated lead-acid batteries for use in portable appliances.

IEC 62485–4 Edition 1.0 2015–01. 

19–29 ................................... American National Standard for Evaluation of Wireless Coexistence .................. IEEE/ANSI C63.27–2017. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 39597 

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

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

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

6–400 ................................... Standard Test Method for Coring Testing of Huber Needles ............................... ASTM F3212–16. 

H. In Vitro Diagnostics (IVD) 

7–272 ................................... Mass Spectrometry for Androgen and Estrogen Measurements in Serum .......... CLSI C57 First edition. 

7–273 ................................... Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry.CLSI M58. 

I. Materials 

8–456 ................................... Implants for surgery—Plasma-sprayed unalloyed titanium coatings on metallic 

surgical implants—Part 1: General requirements.

ISO 13179–1 First edition 2014–06–01. 

8–457 ................................... Implants for surgery—Calcium phosphates—Part 3: Hydroxyapatite and betatricalcium phosphate bone substitutes.ISO 13175–3 First edition 2012–10–01. 

8–458 ................................... Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements.ASTM G5–14. 

8–459 ................................... Pyrometry .............................................................................................................. SAE/AMS2750 Rev. E 2012–07. 

J. Nanotechnology 

18–5 ..................................... Standard Guide for Size Measurement of Nanoparticles Using Atomic Force 

Microscopy.

ASTM E2859–11. 

18–6 ..................................... Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential 

of Nanosized Biological Materials.

ASTM E2865–12. 

18–7 ..................................... Standard Guide for Measurement of Particle Size Distribution of Nanomaterials 

in Suspension by Nanoparticle Tracking Analysis (NTA).

ASTM E2834–12. 

18–8 ..................................... Standard Practice for Calculation of Mean Sizes/Diameters and Standard Deviations of Particle Size Distributions.ASTM E2578–07 (Reapproved 2012). 

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 

11–321 ................................. Standard Specification for Total Elbow Prostheses .............................................. ASTM F2887–17. 

O. Physical Medicine 

16–200 ................................. Wheelchairs—Part 19: Wheeled mobility devices for use as seats in motor vehicles.ISO 7176–19 Second edition 2008–07–15. 

P. Radiology 

No new entries at this time. 

Q. Software/Informatics 

13–89 ................................... Health informatics—Personal health device communication—Part 10406: Device specialization—Basic electrocardiograph (ECG) (1- to 3-lead ECG).ISO/IEEE 11073–10406 First edition 2012–12–01. 

13–90 ................................... Health Informatics—Personal Health Device Communication, Part 10417: Device Specialization—Glucose Meter.IEEE Std 11073–10417–2015. 

13–91 ................................... Health informatics—Personal health device communication—Part 10419: Device specialization—Insulin pump.ISO/IEEE 11073–10419 First edition 2016–06–15. 

13–92 ................................... Health informatics—Personal health device communication—Part 10421: Device specialization—Peak expiratory flow monitor (peak flow).ISO/IEEE 11073–10421 First edition 2012–11–01. 

13–93 ................................... Health informatics—Personal health device communication, Part 10422: Device 

Specialization—Urine Analyzer.

IEEE Std 11073–10422–2016. 

13–94 ................................... Health informatics—Personal health device communication—Part 10424: Device specialization—Sleep Apnoea Breathing Therapy Equipment (SABTE).ISO/IEEE 11073–10424 First edition 2016–06–15. 

13–95 ................................... Health informatics—Personal health device communication—Part 10425: Device specialization—Continuous glucose monitor (CGM).ISO/IEEE 11073–10425 First edition 2016–06–15. 

13–96 ................................... Standard for Software Cybersecurity Network-Connectable Products, Part 1: 

General Requirements.

UL 2900–1 Ed.1 2017. 

13–97 ................................... Health software—Part 1: General requirements for product safety ..................... IEC 82304–1 Edition 1.0 2016–10. 

R. Sterility 

No new entries at this time. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
39598 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

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

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

S. Tissue Engineering 

15–50 ................................... Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds .......... ASTM F2739–16. 

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 in the 

Federal Register, as needed, once a 

year, or more often if necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to 

CDRHStandardsStaff@fda.hhs.gov. To 

be considered, such recommendations 

should contain, at a minimum, the 

following information: (1) Title of the 

standard, (2) any reference number and 

date, (3) name and electronic or mailing 

address of the requestor, (4) a proposed 

list of devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

Dated: August 16, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17603 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–2936] 

Content of Risk Information in the 

Major Statement in Prescription Drug 

Direct-to-Consumer Broadcast 

Advertisements; Establishment of a 

Public Docket; Request for Information 

and Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for information 

and comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is establishing a public docket to 

assist with its development of 

recommendations regarding the 

communication of risk information in 

direct-to-consumer (DTC) broadcast 

advertisements for prescription drugs 

and biologics. 

DATES: Although you can comment at 

any time, to ensure that the Agency 

considers your comment in our 

development of recommendations, 

submit either electronic or written 

information and comments by 

November 20, 2017. 

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– 

2017–N–2936 for ‘‘Content of Risk 

Information in the Major Statement in 

Prescription Drug Direct-to-Consumer 

Broadcast Advertisements.’’ 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. 

• 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES