
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Pages 39591-39598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17603]



[[Page 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

[[Page 39592]]

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
----------------------------------------------------------------------------------------------------------------
                              Replacement
   Old  recognition  No.      recognition            Title of standard \1\                     Change
                                  No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
                                            No new entries at this time.            ............................
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-114.....................           2-246  ASTM F1877--16 Standard Practice for    Withdrawn and replaced with
                                             Characterization of Particles.          newer version.
2-155.....................  ..............  ASTM F2147--01 (Reapproved 2016)        Reaffirmation.
                                             Standard Practice for Guinea Pig:
                                             Split Adjuvant and Closed Patch
                                             Testing for Contact Allergens.
2-177.....................           2-247  ISO 10993-6 Third edition 2016-12-01    Withdrawn and replaced with
                                             Biological evaluation of medical        newer version.
                                             devices--Part 6: Tests for local
                                             effects after implantation.
2-235.....................           2-248  ISO 10993-4 Third edition 2017-04       Withdrawn and replaced with
                                             Biological evaluation of medical        newer version. Extent of
                                             devices--Part 4: Selection of tests     recognition.
                                             for interactions with blood.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-121.....................           3-149  ISO 25539-1 Second edition 2017-02      Withdrawn and replaced with
                                             Cardiovascular implants--Endovascular   newer version.
                                             devices--Part 1: Endovascular
                                             prostheses.
3-142.....................  ..............  ISO/TS 17137 First edition 2014-05-15   Extent of recognition.
                                             Cardiovascular implants and
                                             extracorporeal systems--
                                             Cardiovascular absorbable implants.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-96......................           4-230  ANSI/ADA Standard No. 30-2013/ISO 3107  Withdrawn and replaced with
                                             Dental Zinc Oxide/Eugenol & Zinc        newer version. Extent of
                                             Oxide/Non-Eugenol Cements.              recognition.
4-193.....................  ..............  ANSI/ADA Standard No. 15-2008 (R2013)/  Extent of recognition.
                                             ISO 22112 Artificial Teeth for Dental
                                             Prostheses.
4-215.....................  ..............  ANSI/ADA Standard No. 96-2012 Dental    Extent of recognition.
                                             Water-based Cements.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-90......................           5-117  ISO 15223-1 Third edition 2016-11-01    Withdrawn and replaced with
                                             Medical devices--symbols to be used     newer version.
                                             with medical device labels,
                                             labelling, and information to be
                                             supplied--part 1: General
                                             requirements.
5-91......................           5-118  ANSI/AAMI/ISO 15223-1: 2016 Medical     Withdrawn and replaced with
                                             devices--symbols to be used with        newer version.
                                             medical device labels, labelling, and
                                             information to be supplied--part 1:
                                             General requirements.
5-107.....................  ..............  IEC 80369-5: Edition 1.0 2016-03 Small- Technical corrigendum added.
                                             bore connectors for liquids and gases
                                             in healthcare applications--Part 5:
                                             Connectors for limb cuff inflation
                                             applications [Including CORRIGENDUM 1
                                             (2017)].
----------------------------------------------------------------------------------------------------------------

[[Page 39593]]

 
                    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)          Reaffirmation.
                                             Standard Specification for Phase
                                             Change-Type Disposable Fever
                                             Thermometer for Intermittent
                                             Determination of Human Temperature.
6-124.....................  ..............  ASTM E1104-98 (Reapproved 2016)         Reaffirmation
                                             Standard Specification for Clinical
                                             Thermometer Probe Covers and Sheaths.
6-125.....................  ..............  ASTM E1965-98 (Reapproved 2016)         Reaffirmation.
                                             Standard Specification for Infrared
                                             Thermometers for Intermittent
                                             Determination of Patient Temperature.
6-297.....................           6-384  ISO 1135-4 Sixth edition 2015-12-01     Withdrawn and replaced with
                                             Transfusion equipment for medical use-  newer version.
                                             Part 4: Transfusion sets for single
                                             use, gravity feed.
6-319.....................           6-385  IEC 60601-2-19 Edition 2.1 2016-04      Withdrawn and replaced with
                                             CONSOLIDATED VERSION Medical            newer version including
                                             electrical equipment--Part 2-19:        amendment.
                                             Particular requirements for the basic
                                             safety and essential performance of
                                             infant incubators [Including
                                             AMENDMENT 1 (2016)].
6-320.....................           6-386  IEC 60601-2-20 Edition 2.1 2016-04      Withdrawn and replaced with
                                             CONSOLIDATED VERSION Medical            newer version including
                                             electrical equipment--Part 2-20:        amendment.
                                             Particular requirements for the basic
                                             safety and essential performance of
                                             infant transport incubators
                                             [Including AMENDMENT 1 (2016)].
6-324.....................           6-387  IEC 60601-2-50 Edition 2.1 2016-04      Withdrawn and replaced with
                                             CONSOLIDATED VERSION Medical            newer version including
                                             electrical equipment--Part 2-50:        amendment.
                                             Particular requirements for the basic
                                             safety and essential performance of
                                             infant phototherapy equipment
                                             [Including AMENDMENT 1 (2016)].
6-325.....................           6-388  IEC 60601-2-21 Edition 2.1 2016-04      Withdrawn and replaced with
                                             CONSOLIDATED VERSION Medical            newer version including
                                             electrical equipment--Part 2-21:        amendment.
                                             Particular requirements for the basic
                                             safety and essential performance of
                                             infant radiant warmers [Including
                                             AMENDMENT 1 (2016)].
6-336.....................           6-389  IEC 60601-2-2 Edition 6.0 2017-03       Withdrawn and replaced with
                                             Medical electrical equipment--Part 2-   newer version.
                                             2: Particular requirements for the
                                             basic safety and essential
                                             performance of high frequency
                                             surgical equipment and high frequency
                                             surgical accessories.
6-342.....................           6-390  IEC 80601-2-35 Edition 2.1 2016-04      Withdrawn and replaced with
                                             CONSOLIDATED VERSION Medical            newer version including
                                             electrical equipment--Part 2-35:        amendment.
                                             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)].
6-367.....................           6-391  USP 40-NF35:2017, Sodium Chloride       Withdrawn and replaced with
                                             Irrigation.                             newer version.
6-368.....................           6-392  USP 40-NF35:2017, Sodium Chloride       Withdrawn and replaced with
                                             Injection.                              newer version.
6-369.....................           6-393  USP 40-NF35:2017, Nonabsorbable         Withdrawn and replaced with
                                             Surgical Suture.                        newer version.
6-370.....................           6-394  USP 40-NF35:2017, <881> Tensile         Withdrawn and replaced with
                                             Strength.                               newer version.
6-371.....................           6-395  USP 40-NF35:2017, <861> Sutures--       Withdrawn and replaced with
                                             Diameter.                               newer version.
6-372.....................           6-396  USP 40-NF35:2017, <871> Sutures--       Withdrawn and replaced with
                                             Needle Attachment.                      newer version.
6-373.....................           6-397  USP 40-NF35:2017, Sterile Water for     Withdrawn and replaced with
                                             Irrigation.                             newer version.
6-374.....................           6-398  USP 40-NF35:2017, Heparin Lock Flush    Withdrawn and replaced with
                                             Solution.                               newer version.
6-375.....................           6-399  USP 40-NF35:2017, Absorbable Surgical   Withdrawn and replaced with
                                             Suture.                                 newer version.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-206.....................           7-270  I/LA-20 3rd Edition Analytical          Withdrawn and replaced with
                                             Performance Characteristics, Quality    newer version.
                                             Assurance, and Clinical Utility of
                                             Immunological Assays for Human
                                             Immunoglobulin E Antibodies of
                                             Defined Allergen Specificities.

[[Page 39594]]

 
7-263.....................           7-271  CLSI M100 27th Edition Performance      Withdrawn and replaced with
                                             Standards for Antimicrobial             newer version.
                                             Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-58......................           8-447  ISO 5832-3 Fourth edition 2016-10-15    Withdrawn and replaced with
                                             Implants for surgery--Metallic          newer version. Extent of
                                             materials--Part 3: Wrought titanium 6-  recognition.
                                             aluminium 4-vanadium alloy.
8-125.....................           8-448  ASTM F2004-16 Standard Test Method for  Withdrawn and replaced with
                                             Transformation Temperature of Nickel-   newer version.
                                             Titanium Alloys by Thermal Analysis.
8-165.....................           8-449  ASTM F1058-16 Standard Specification    Withdrawn and replaced with
                                             for Wrought 40Cobalt-20 Chromium-       newer version.
                                             16Iron-15Nickel-7Molybdenum Alloy
                                             Wire, Strip, and Strip Bar for
                                             Surgical Implant Applications (UNS
                                             R30003 and UNS R30008).
8-185.....................           8-450  ASTM F451-16 Standard Specification     Withdrawn and replaced with
                                             for Acrylic Bone Cement.                newer version.
8-187.....................  ..............  ISO 13779-1:2008 Second edition 2008-   Withdrawn.
                                             10-01 Implants for surgery--
                                             Hydroxyapatite--Part 1: Ceramic
                                             hydroxyapatite.
8-195.....................  ..............  ASTM F2024-10 (Reapproved 2016)         Reaffirmation.
                                             Standard Practice for X-ray
                                             Diffraction Determination of Phase
                                             Content of Plasma-Sprayed
                                             Hydroxyapatite Coatings.
8-201.....................           8-451  ASTM F2214-16 Standard Test Method for  Withdrawn and replaced with
                                             In Situ Determination of Network        newer version.
                                             Parameters of Crosslinked Ultra High
                                             Molecular Weight Polyethylene
                                             (UHMWPE).
8-202.....................  ..............  ASTM F2183-02 (Reapproved 2008)         Withdrawn.
                                             Standard Test Method for Small Punch
                                             Testing of Ultra-High Molecular
                                             Weight Polyethylene Used in Surgical
                                             Implants (Withdrawn 2017).
8-205.....................           8-452  ASTM F1635-16 Standard Test Method for  Withdrawn and replaced with
                                             in vitro Degradation Testing of         newer version.
                                             Hydrolytically Degradable Polymer
                                             Resins and Fabricated Forms for
                                             Surgical Implants.
8-216.....................           8-453  ASTM F1295-16 Standard Specification    Withdrawn and replaced with
                                             for Wrought Titanium-6 Aluminum-        newer version.
                                             7Niobium Alloy for Surgical Implant
                                             Applications (UNS R56700).
8-226.....................  ..............  ASTM F603-12 (Reapproved 2016)          Reaffirmation.
                                             Standard Specification for High-
                                             Purity Dense Aluminum Oxide for
                                             Medical Application.
8-333.....................  ..............  ASTM F2393-12 (Reapproved 2016)         Reaffirmation.
                                             Standard Specification for High-
                                             Purity Dense Magnesia Partially
                                             Stabilized Zirconia (Mg-PSZ) for
                                             Surgical Implant Applications.
8-396.....................           8-454  ASTM F2129-17 Standard Test Method for  Withdrawn and replaced with
                                             Conducting Cyclic Potentiodynamic       newer version.
                                             Polarization Measurements to
                                             Determine the Corrosion
                                             Susceptibility of Small Implant
                                             Devices.
8-428.....................  ..............  ASTM F1581-08 (Reapproved 2016)         Reaffirmation.
                                             Standard Specification for
                                             Composition of Anorganic Bone for
                                             Surgical Implants.
8-410.....................           8-455  ASTM F2902-16 Standard Guide for        Withdrawn and replaced with
                                             Assessment of Absorbable Polymeric      newer version.
                                             Implants.
----------------------------------------------------------------------------------------------------------------
                                                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      Withdrawn and replaced with
                                             Standard for Ophthalmics--Contact       newer version.
                                             Lens Care Products--Vocabulary,
                                             Performance Specifications, and Test
                                             Methodology.
10-92.....................          10-104  ANSI Z80.20-2016 American National      Withdrawn and replaced with
                                             Standard for Ophthalmics--Contact       newer version.
                                             Lenses--Standard Terminology,
                                             Tolerances, Measurements and
                                             Physicochemical Properties.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-175....................  ..............  ASTM F1582-98 (Reapproved 2016)         Reaffirmation.
                                             Standard Terminology Relating to
                                             Spinal Implants.

[[Page 39595]]

 
11-242....................  ..............  ASTM F1839-08 (Reapproved 2016)         Reaffirmation.
                                             Standard Specification for Rigid
                                             Polyurethane Foam for Use as a
                                             Standard Material for Testing
                                             Orthopaedic Devices and Instruments.
11-269....................  ..............  ASTM F2423-11 (Reapproved 2016)         Reaffirmation.
                                             Standard Guide for Functional,
                                             Kinematic, and Wear Assessment of
                                             Total Disc Prostheses.
11-280....................  ..............  ASTM F2624-12 (Reapproved 2016)         Reaffirmation.
                                             Standard Test Method for Static,
                                             Dynamic, and Wear Assessment of Extra-
                                             Discal Single Level Spinal Constructs.
11-309....................  ..............  ASTM F116-12 (Reapproved 2016)          Reaffirmation.
                                             Standard Specification for Medical
                                             Screwdriver Bits.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
                                            No new entries at this time.            ............................
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-234....................          12-306  NEMA MS 12-2016 Quantification and      Withdrawn and replaced with
                                             Mapping of Geometric Distortion for     newer version.
                                             Special Applications.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-66.....................           13-88  ISO/IEEE 11073-10417 Third edition      Withdrawn and replaced with
                                             2017-04 Health informatics--Personal    newer version.
                                             health device communication--Part
                                             10417: Device specialization--Glucose
                                             meter.
13-67.....................  ..............  ISO/IEEE 11073-10418 First edition      Technical Corrigendum added.
                                             2014-03-01 Health informatics--
                                             Personal health device communication--
                                             Part 10418: Device specialization:
                                             International Normalized Ratio (INR)
                                             monitor [including TECHNICAL
                                             CORRIGENDUM 1 (2016)].
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-288....................          14-501  ASTM F1886/F1886M-16 Standard Test      Withdrawn and replaced with
                                             Method for Determining Integrity of     newer version.
                                             Seals for Flexible Packaging by
                                             Visual Inspection.
14-338....................          14-502  ISO 11138-1 Third edition 2017-03       Withdrawn and replaced with
                                             Sterilization of health care            newer version.
                                             products--Biological indicators--Part
                                             1: General requirements.
14-358....................  ..............  ANSI/AAMI/ISO 14160:2011/(R)2016        Reaffirmation. Extent of
                                             Sterilization of health care            recognition.
                                             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.
14-361....................  ..............  ISO 14160 Second edition 2011-07-01     Extent of recognition.
                                             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.
14-485....................          14-503  USP 40-NF35:2017, <61> Microbiological  Withdrawn and replaced with
                                             Examination of Nonsterile Products:     newer version.
                                             Microbial Enumeration Tests.
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        Withdrawn and replaced with
                                             Endotoxins Test.                        newer version.
14-488....................          14-506  USP 40-NF35:2017, <161> Medical         Withdrawn and replaced with
                                             Devices-Bacterial Endotoxin and         newer version.
                                             Pyrogen Tests.
14-493....................          14-507  USP 40-NF35:2017, <62> Microbiological  Withdrawn and replaced with
                                             Examination of Nonsterile Products:     newer version.
                                             Tests for Specified Microorganisms.
14-494....................          14-508  USP 40-NF35:2017, <55> Biological       Withdrawn and replaced with
                                             Indicators--Resistance Performance      newer version.
                                             Tests.
14-495....................          14-509  USP 40-NF35:2017, <1229.5> Biological   Withdrawn and replaced with
                                             Indicators for Sterilization.           newer version.
----------------------------------------------------------------------------------------------------------------

[[Page 39596]]

 
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-20.....................           15-49  ASTM F2027-16 Standard Guide for        Withdrawn and replaced with
                                             Characterization and Testing of Raw     newer version.
                                             or Starting Materials for Tissue-
                                             Engineered Medical Products.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 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--   ISO 5359 Fourth edition 2014-
                                         Low-pressure hose assemblies for use      10-01.
                                         with medical gases.
1-122.................................  Anaesthetic and respiratory equipment--   ISO 5364 Fifth edition 2016-09-
                                         Oropharyngeal airways.                    01.
1-123.................................  Anaesthetic and respiratory equipment--   ISO 7376 Second edition 2009-
                                         Laryngoscopes for tracheal intubation.    08-15.
1-124.................................  Inhalational anaesthesia systems--Part    ISO 8835-7 First edition 2011-
                                         7: Anaesthetic systems for use in areas   11-01.
                                         with limited logistical supplies of
                                         electricity and anaesthetic gases.
1-125.................................  Suction catheters for use in the          ISO 8836 Fourth edition 2014-
                                         respiratory tract.                        10-15.
1-126.................................  Anaesthetic and respiratory equipment--   ISO 11712 First edition 2009-
                                         Supralaryngeal airways and connectors.    05-15.
1-127.................................  Tracheobronchial tubes--Sizing and        ISO 16628 First edition 2008-
                                         marking.                                  11-15.
1-128.................................  Anaesthetic and respiratory equipment--   ISO 18082 First edition 2014-
                                         Dimensions of noninterchangeable screw-   06-15.
                                         threaded (NIST) low-pressure connectors
                                         for medical gases.
----------------------------------------------------------------------------------------------------------------
                                               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   ISO/TS 11405 Third edition
                                         structure.                                2015-02-01.
4-232.................................  Dentistry--Base polymers--Part 1:         ISO 20795-1 Second edition
                                         Denture base polymers.                    2013-03-01.
4-233.................................  Dentistry--Base polymers--Part 2:         ISO 20795-2 Second edition
                                         Orthodontic base polymers.                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  ISO 20127 First edition 2005-
                                         requirements and test methods.            03-15.
4-239.................................  Cochlear Implant Systems: Requirements    ANSI/AAMI CI 86:2017.
                                         for Safety, Functional Verification,
                                         Labeling and Reliability Reporting.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-119.................................  Small-bore connectors for liquids and     ANSI/AAMI/ISO 80369-5: 2016.
                                         gases in healthcare applications--Part
                                         5: Connectors for limb cuff inflation
                                         applications.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-22.................................  Technical Information Report Risk         AAMI TIR69: 2017.
                                         management of radio-frequency wireless
                                         coexistence for medical devices and
                                         systems.
19-23.................................  Primary batteries--Part 4: Safety of      IEC 60086-4 Edition 4.0 2014-
                                         lithium batteries.                        09.
19-24.................................  Primary batteries--Part 5: Safety of      IEC 60086-5 Edition 4.0 2016-
                                         batteries with aqueous electrolyte.       07.
19-25.................................  Safety requirements for secondary         IEC 62485-1 Edition 1.0 2015-
                                         batteries and battery installations--     04.
                                         Part 1: General safety information.
19-26.................................  Safety requirements for secondary         IEC 62485-2 Edition 1.0 2010-
                                         batteries and battery installations--     06.
                                         Part 2: Stationary batteries.
19-27.................................  Safety requirements for secondary         IEC 62485-3 Edition 2.0 2014-
                                         batteries and battery installations--     07.
                                         Part 3: Traction batteries.
19-28.................................  Safety requirements for secondary         IEC 62485-4 Edition 1.0 2015-
                                         batteries and battery installations--     01.
                                         Part 4: Valve-regulated lead-acid
                                         batteries for use in portable
                                         appliances.
19-29.................................  American National Standard for            IEEE/ANSI C63.27-2017.
                                         Evaluation of Wireless Coexistence.
----------------------------------------------------------------------------------------------------------------

[[Page 39597]]

 
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-400.................................  Standard Test Method for Coring Testing   ASTM F3212-16.
                                         of Huber Needles.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-272.................................  Mass Spectrometry for Androgen and        CLSI C57 First edition.
                                         Estrogen Measurements in Serum.
7-273.................................  Methods for the Identification of         CLSI M58.
                                         Cultured Microorganisms Using Matrix-
                                         Assisted Laser Desorption/Ionization
                                         Time-of-Flight Mass Spectrometry.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-456.................................  Implants for surgery--Plasma-sprayed      ISO 13179-1 First edition 2014-
                                         unalloyed titanium coatings on metallic   06-01.
                                         surgical implants--Part 1: General
                                         requirements.
8-457.................................  Implants for surgery--Calcium             ISO 13175-3 First edition 2012-
                                         phosphates--Part 3: Hydroxyapatite and    10-01.
                                         beta-tricalcium phosphate bone
                                         substitutes.
8-458.................................  Standard Reference Test Method for        ASTM G5-14.
                                         Making Potentiodynamic Anodic
                                         Polarization Measurements.
8-459.................................  Pyrometry...............................  SAE/AMS2750 Rev. E 2012-07.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-5..................................  Standard Guide for Size Measurement of    ASTM E2859-11.
                                         Nanoparticles Using Atomic Force
                                         Microscopy.
18-6..................................  Standard Guide for Measurement of         ASTM E2865-12.
                                         Electrophoretic Mobility and Zeta
                                         Potential of Nanosized Biological
                                         Materials.
18-7..................................  Standard Guide for Measurement of         ASTM E2834-12.
                                         Particle Size Distribution of
                                         Nanomaterials in Suspension by
                                         Nanoparticle Tracking Analysis (NTA).
18-8..................................  Standard Practice for Calculation of      ASTM E2578-07 (Reapproved
                                         Mean Sizes/Diameters and Standard         2012).
                                         Deviations of Particle Size
                                         Distributions.
----------------------------------------------------------------------------------------------------------------
                                                  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    ASTM F2887-17.
                                         Prostheses.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-200................................  Wheelchairs--Part 19: Wheeled mobility    ISO 7176-19 Second edition
                                         devices for use as seats in motor         2008-07-15.
                                         vehicles.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
                                        No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-89.................................  Health informatics--Personal health       ISO/IEEE 11073-10406 First
                                         device communication--Part 10406:         edition 2012-12-01.
                                         Device specialization--Basic
                                         electrocardiograph (ECG) (1- to 3-lead
                                         ECG).
13-90.................................  Health Informatics--Personal Health       IEEE Std 11073-10417-2015.
                                         Device Communication, Part 10417:
                                         Device Specialization--Glucose Meter.
13-91.................................  Health informatics--Personal health       ISO/IEEE 11073-10419 First
                                         device communication--Part 10419:         edition 2016-06-15.
                                         Device specialization--Insulin pump.
13-92.................................  Health informatics--Personal health       ISO/IEEE 11073-10421 First
                                         device communication--Part 10421:         edition 2012-11-01.
                                         Device specialization--Peak expiratory
                                         flow monitor (peak flow).
13-93.................................  Health informatics--Personal health       IEEE Std 11073-10422-2016.
                                         device communication, Part 10422:
                                         Device Specialization--Urine Analyzer.
13-94.................................  Health informatics--Personal health       ISO/IEEE 11073-10424 First
                                         device communication--Part 10424:         edition 2016-06-15.
                                         Device specialization--Sleep Apnoea
                                         Breathing Therapy Equipment (SABTE).
13-95.................................  Health informatics--Personal health       ISO/IEEE 11073-10425 First
                                         device communication--Part 10425:         edition 2016-06-15.
                                         Device specialization--Continuous
                                         glucose monitor (CGM).
13-96.................................  Standard for Software Cybersecurity       UL 2900-1 Ed.1 2017.
                                         Network-Connectable Products, Part 1:
                                         General Requirements.
13-97.................................  Health software--Part 1: General          IEC 82304-1 Edition 1.0 2016-
                                         requirements for product safety.          10.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
                                        No new entries at this time.
----------------------------------------------------------------------------------------------------------------

[[Page 39598]]

 
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-50.................................  Standard Guide for Quantifying Cell       ASTM F2739-16.
                                         Viability within Biomaterial Scaffolds.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 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


