[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53264-53271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22977]


-----------------------------------------------------------------------

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: 050

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: 050'' (Recognition List Number: 050), 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 October 22, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 050.'' 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: 050.
     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: http://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: 050 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: 
050 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: 050'' 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, 
[email protected].

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

[[Page 53265]]

premarket review submissions or other requirements.
    In the Federal Register notice of September 13, 2018 (83 FR 46738), 
FDA announced the availability of a guidance entitled ``Appropriate use 
of Voluntary Consensus Standards in Premarket Submission for Medical 
Devices.'' The guidance describes how FDA has implemented its standard 
recognition program and is available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. Modifications to the initial list of recognized 
standards, as published in the Federal Register, can be accessed at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Additional information 
on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 050

    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: 050'' 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     recognition   Title of standard      Change \2\
        No.               No.              \1\
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-85..............           1-139  ISO 80601-2-61     Withdrawn and
                                     Second edition     replaced with
                                     2017-12            newer version.
                                     (Corrected
                                     version 2018-02)
                                     Medical
                                     electrical
                                     equipment--Part
                                     2-61: Particular
                                     requirements for
                                     basic safety and
                                     essential
                                     performance of
                                     pulse oximeter
                                     equipment.
1-96..............           1-140  ISO 80601-2-55     Withdrawn and
                                     Second edition     replaced with
                                     2018-02 Medical    newer version.
                                     electrical
                                     equipment--Part
                                     2-55: Particular
                                     requirements for
                                     the basic safety
                                     and essential
                                     performance of
                                     respiratory gas
                                     monitors.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-176.............           2-255  ISO 10993-11       Withdrawn and
                                     Third edition      replaced with
                                     2017-09            newer version.
                                     Biological
                                     evaluation of
                                     medical devices--
                                     Part 11: Tests
                                     for systemic
                                     toxicity.
2-204.............           2-256  ASTM F720-17       Withdrawn and
                                     Standard           replaced with
                                     Practice for       newer version.
                                     Testing Guinea
                                     Pigs for Contact
                                     Allergens:
                                     Guinea Pig
                                     Maximization
                                     Test.
2-233.............           2-257  ASTM F2382-17e1    Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Assessment of
                                     Circulating
                                     Blood-Contacting
                                     Medical Device
                                     Materials on
                                     Partial
                                     Thromboplastin
                                     Time (PTT).
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-110.............  ..............  AAMI TIR41:2011/   Reaffirmation.
                                     (R)2017
                                     Technical
                                     Information
                                     Report Active
                                     implantable
                                     medical devices--
                                     Guidance for
                                     designation of
                                     left ventricle
                                     and implantable
                                     cardioverter
                                     defibrillator
                                     lead connectors
                                     and pulse
                                     generator
                                     connector
                                     cavities for
                                     implantable
                                     pacemakers and
                                     implantable
                                     cardioverter
                                     defibrillators.
3-123.............           3-152  IEC 80601-2-30     Withdrawn and
                                     Edition 1.1 2013-  replaced with
                                     07 Medical         newer version.
                                     electrical
                                     equipment--Part
                                     2-30: Particular
                                     requirements for
                                     the basic safety
                                     and essential
                                     performance of
                                     automated non-
                                     invasive
                                     sphygmomanometer
                                     s.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-214.............           4-242  ISO 10139-1 Third  Withdrawn and
                                     edition 2018-03    replaced with
                                     Dentistry--Soft    newer version.
                                     lining materials
                                     for removable
                                     dentures--Part
                                     1: Materials for
                                     short-term use.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-42..............  ..............  ASTM D903-98       Reaffirmation.
                                     (Reapproved
                                     2017) Standard
                                     Test Method for
                                     Peel or
                                     Stripping
                                     Strength of
                                     Adhesive Bonds.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-8..............  ..............  IEC 60601-1-2      Extent of
                                     Edition 4.0 2014-  recognition.
                                     02 Medical
                                     electrical
                                     equipment--Part
                                     1-2: General
                                     requirements for
                                     basic safety and
                                     essential
                                     performance--Col
                                     lateral
                                     Standard:
                                     Electromagnetic
                                     disturbances--Re
                                     quirements and
                                     tests.
19-19.............  ..............  IEC TR 60601-4-2   Extent of
                                     Edition 1.0 2016-  recognition.
                                     05 Medical
                                     electrical
                                     equipment--Part
                                     4-2: Guidance
                                     and
                                     interpretation--
                                     Electromagnetic
                                     immunity:
                                     performance of
                                     medical
                                     electrical
                                     equipment and
                                     medical
                                     electrical
                                     systems.

[[Page 53266]]

 
19-21.............           19-30  AIM Standard       Withdrawn and
                                     7351731 Rev.       replaced with
                                     2.00 Medical       newer version.
                                     Electrical
                                     Equipment and
                                     System
                                     Electromagnetic
                                     Immunity Test
                                     for Exposure to
                                     Radio Frequency
                                     Identification
                                     Readers--An AIM
                                     Standard.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-123.............  ..............  ASTM E667-98       Reaffirmation.
                                     (Reapproved
                                     2017) Standard
                                     Specification
                                     for
                                     Mercury[hyphen]i
                                     n[hyphen]Glass,
                                     Maximum
                                     Self[hyphen]Regi
                                     stering Clinical
                                     Thermometers.
6-254.............  ..............  ASTM F2100-11      Reaffirmation.
                                     (Reapproved
                                     2018) Standard
                                     Specification
                                     for Performance
                                     of Materials
                                     Used in Medical
                                     Face Masks.
6-301.............           6-408  ISO 10555-1        Withdrawn and
                                     Second edition     replaced with
                                     2013-06-15         newer version
                                     Intravascular      including
                                     catheters--Steri   amendment.
                                     le and single-
                                     use catheters--
                                     Part 1: General
                                     requirements
                                     [Including
                                     AMENDMENT 1
                                     (2017)].
6-352.............           6-409  ASTM F703-18       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Implantable
                                     Breast
                                     Prostheses.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-127.............           7-275  CLSI EP07 3rd      Withdrawn and
                                     Edition            replaced with
                                     Interference       newer version.
                                     Testing in
                                     Clinical
                                     Chemistry.
7-171.............           7-276  CLSI M38 3rd       Withdrawn and
                                     Edition            replaced with
                                     Reference Method   newer version.
                                     for Broth
                                     Dilution
                                     Antifungal
                                     Susceptibility
                                     Testing of
                                     Filamentous
                                     Fungi.
7-201.............           7-277  CLSI GP41 7th      Withdrawn and
                                     Edition            replaced with
                                     Collection of      newer version.
                                     Diagnostic
                                     Venous Blood
                                     Specimens.
7-204.............           7-278  CLSI M27 4th       Withdrawn and
                                     Edition            replaced with
                                     Reference Method   newer version.
                                     for Broth
                                     Dilution
                                     Antifungal
                                     Susceptibility
                                     Testing of
                                     Yeasts.
7-217.............  ..............  CLSI M60 1st       Title change.
                                     Edition
                                     Performance
                                     Standards for
                                     Antifungal
                                     Susceptibility
                                     Testing of
                                     Yeasts.
7-240.............  ..............  CLSI M27-S4        Withdrawn. See 7-
                                     Reference Method   217.
                                     for Broth
                                     Dilution
                                     Antifungal
                                     Susceptibility
                                     Testing of
                                     Yeasts; Fourth
                                     Informational
                                     Supplement.
7-245.............  ..............  CLSI EP09-A3       Withdrawn.
                                     Measurement
                                     Procedure
                                     Comparison and
                                     Bias Estimation
                                     Using Patient
                                     Samples;
                                     Approved
                                     Guideline--Third
                                     Edition.
7-254.............           7-279  CLSI M07 11th      Withdrawn and
                                     Edition Methods    replaced with
                                     for Dilution       newer version.
                                     Antimicrobial
                                     Susceptibility
                                     Tests for
                                     Bacteria That
                                     Grow Aerobically.
7-258.............           7-280  CLSI M02 13th      Withdrawn and
                                     Edition            replaced with
                                     Performance        newer version.
                                     Standards for
                                     Antimicrobial
                                     Disk
                                     Susceptibility
                                     Tests.
7-271.............           7-281  CLSI M100 28th     Withdrawn and
                                     Edition            replaced with
                                     Performance        newer version.
                                     Standards for
                                     Antimicrobial
                                     Susceptibility
                                     Testing.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-57..............           8-465  ISO 5832-2 Fourth  Withdrawn and
                                     edition 2018-03    replaced with
                                     Implants for       newer version.
                                     surgery--Metalli
                                     c materials--
                                     Part 2:
                                     Unalloyed
                                     titanium.
8-112.............  ..............  ASTM F1044-05      Reaffirmation.
                                     (Reapproved
                                     2017)e1 Standard
                                     Test Method for
                                     Shear Testing of
                                     Calcium
                                     Phosphate
                                     Coatings and
                                     Metallic
                                     Coatings.
8-128.............           8-466  ASTM F2213-17      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Measurement of
                                     Magnetically
                                     Induced Torque
                                     on Medical
                                     Devices in the
                                     Magnetic
                                     Resonance
                                     Environment.
8-330.............           8-467  ASTM F1978-18      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Measuring
                                     Abrasion
                                     Resistance of
                                     Metallic Thermal
                                     Spray Coatings
                                     by Using the
                                     Taber Abraser.
8-334.............           8-468  ASTM F2459-18      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Extracting
                                     Residue from
                                     Metallic Medical
                                     Components and
                                     Quantifying via
                                     Gravimetric
                                     Analysis.
8-372.............           8-469  ASTM F560-17       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Unalloyed
                                     Tantalum for
                                     Surgical Implant
                                     Applications
                                     (UNS R05200, UNS
                                     R05400).
8-380.............  ..............  ASTM F1160-14      Reaffirmation.
                                     (Reapproved
                                     2017)e1 Standard
                                     Test Method for
                                     Shear and
                                     Bending Fatigue
                                     Testing of
                                     Calcium
                                     Phosphate and
                                     Metallic Medical
                                     and Composite
                                     Calcium
                                     Phosphate/
                                     Metallic
                                     Coatings.
8-382.............           8-470  ASTM F2102-17      Withdrawn and
                                     Standard Guide     replaced with
                                     for Evaluating     newer version.
                                     the Extent of
                                     Oxidation in
                                     Polyethylene
                                     Fabricated Forms
                                     Intended for
                                     Surgical
                                     Implants.
8-390.............           8-471  ASTM F1925-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Semi-
                                     Crystalline
                                     Poly(lactide)
                                     Polymer and
                                     Copolymer Resins
                                     for Surgical
                                     Implants.
8-412.............  ..............  ASTM F2537-06      Reaffirmation.
                                     (Reapproved
                                     2017) Standard
                                     Practice for
                                     Calibration of
                                     Linear
                                     Displacement
                                     Sensor Systems
                                     Used to Measure
                                     Micromotion.
8-414.............           8-472  ASTM F2847-17      Withdrawn and
                                     Standard           replaced with
                                     Practice for       newer version.
                                     Reporting and
                                     Assessment of
                                     Residues on
                                     Single-Use
                                     Implants and
                                     Single-Use
                                     Sterile
                                     Instruments.
8-419.............           8-473  ASTM F2885-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Metal          Extent of
                                     Injection Molded   recognition.
                                     Titanium-
                                     6Aluminum-
                                     4Vanadium
                                     Components for
                                     Surgical Implant
                                     Applications.
8-420.............           8-474  ASTM F2886-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Metal
                                     Injection Molded
                                     Cobalt-
                                     28Chromium-
                                     6Molybdenum
                                     Components for
                                     Surgical Implant
                                     Applications.

[[Page 53267]]

 
8-436.............           8-475  ASTM F2026-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for
                                     Polyetheretherke
                                     tone (PEEK)
                                     Polymers for
                                     Surgical Implant
                                     Applications.
8-448.............           8-476  ASTM F2004-17      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Transformation
                                     Temperature of
                                     Nickel-Titanium
                                     Alloys by
                                     Thermal Analysis.
8-454.............           8-477  ASTM F2129-17b     Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Conducting
                                     Cyclic
                                     Potentiodynamic
                                     Polarization
                                     Measurements to
                                     Determine the
                                     Corrosion
                                     Susceptibility
                                     of Small Implant
                                     Devices.
------------------------------------------------------------------------
                            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)
------------------------------------------------------------------------
9-43..............           9-117  ISO 16038 Second   Withdrawn and
                                     edition 2017-11    replaced with
                                     Male condoms--     newer version.
                                     Guidance on the
                                     use of ISO 4074
                                     and ISO 23409 in
                                     the quality
                                     management of
                                     condoms.
9-67..............  ..............  ASTM D7661-10      Reaffirmation.
                                     (Reapproved
                                     2017) Standard
                                     Test Method for
                                     Determining
                                     Compatibility of
                                     Personal
                                     Lubricants with
                                     Natural Rubber
                                     Latex Condoms.
9-92..............           9-118  ISO 8637-1 First   Withdrawn and
                                     edition 2017-11    replaced with
                                     Extracorporeal     newer version.
                                     systems for
                                     blood
                                     purification--Pa
                                     rt 1:
                                     Haemodialysers,
                                     haemodiafilters,
                                     haemofilters and
                                     haemoconcentrato
                                     rs.
9-95..............           9-119  IEC 60601-2-36     Withdrawn and
                                     Edition 2.0 2014-  replaced with
                                     04 Medical         new recognition
                                     electrical         number.
                                     equipment--Part
                                     2-36: Particular
                                     requirements for
                                     the safety of
                                     equipment for
                                     extracorporeally
                                     induced
                                     lithotripsy.
9-112.............           9-120  ASTM D3492-16      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Rubber
                                     Contraceptives
                                     (Male Condoms).
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-56.............  ..............  ANSI Z80.12-2007   Reaffirmation.
                                     (R2017) American
                                     National
                                     Standard for
                                     Ophthalmics--Mul
                                     tifocal
                                     Intraocular
                                     Lenses.
10-57.............  ..............  ANSI Z80.13-2007   Reaffirmation.
                                     (R2017) American
                                     National
                                     Standard for
                                     Ophthalmics--Pha
                                     kic Intraocular
                                     Lenses.
10-60.............          10-111  ISO 11981 Third    Withdrawn and
                                     edition 2017-11    replaced with
                                     Ophthalmic         newer version.
                                     optics--Contact
                                     lenses and
                                     contact lens
                                     care products--
                                     Determination of
                                     physical
                                     compatibility of
                                     contact lens
                                     care products
                                     with contact
                                     lenses.
10-67.............          10-112  ISO 11986 Third    Withdrawn and
                                     edition 2017-11    replaced with
                                     Ophthalmic         newer version.
                                     optics--Contact
                                     lenses and
                                     contact lens
                                     care products--
                                     Determination of
                                     preservative
                                     uptake and
                                     release.
10-84.............  ..............  ANSI Z80.11-2012   Reaffirmation.
                                     (R2017) American
                                     National
                                     Standard for
                                     Ophthalmics--Las
                                     er Systems for
                                     Corneal
                                     Reshaping.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-185............  ..............  ASTM F2267-04      Reaffirmation.
                                     (Reapproved
                                     2018) Standard
                                     Test Method for
                                     Measuring Load
                                     Induced
                                     Subsidence of
                                     Intervertebral
                                     Body Fusion
                                     Device Under
                                     Static Axial
                                     Compression.
11-197............  ..............  ASTM F983-86       Reaffirmation.
                                     (Reapproved
                                     2018) Standard
                                     Practice for
                                     Permanent
                                     Marking of
                                     Orthopaedic
                                     Implant
                                     Components.
11-199............  ..............  ASTM F565-04       Reaffirmation.
                                     (Reapproved
                                     2018) Standard
                                     Practice for
                                     Care and
                                     Handling of
                                     Orthopedic
                                     Implants and
                                     Instruments.
11-203............          11-322  ASTM F1541-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     and Test Methods
                                     for External
                                     Skeletal
                                     Fixation Devices.
11-224............          11-323  ASTM F2706-17      Withdrawn and
                                     Standard Test      replaced with
                                     Methods for        newer version.
                                     Occipital-
                                     Cervical and
                                     Occipital-
                                     Cervical-
                                     Thoracic Spinal
                                     Implant
                                     Constructs in a
                                     Vertebrectomy
                                     Model.
11-226............           8-478  ASTM F1089-18      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Corrosion of       Transferred.
                                     Surgical
                                     Instruments.
11-227............          11-324  ASTM F366-17       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Fixation
                                     Pins and Wires.
11-228............          11-325  ASTM F564-17       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     and Test Methods
                                     for Metallic
                                     Bone Staples.
11-245............          11-326  ASTM F384-17       Withdrawn and
                                     Standard           replaced with
                                     Specifications     newer version.
                                     and Test Methods
                                     for Metallic
                                     Angled
                                     Orthopedic
                                     Fracture
                                     Fixation Devices.
11-257............          11-327  ASTM F543-17       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     and Test Methods
                                     for Metallic
                                     Medical Bone
                                     Screws.
11-261............          11-328  ASTM F1378-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Shoulder
                                     Prostheses.

[[Page 53268]]

 
11-271............          11-329  ASTM F2180-17      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     for Metallic
                                     Implantable
                                     Strands and
                                     Cables.
11-284............          11-330  ASTM F2028-17      Withdrawn and
                                     Standard Test      replaced with
                                     Methods for        newer version.
                                     Dynamic
                                     Evaluation of
                                     Glenoid
                                     Loosening or
                                     Disassociation.
11-288............          11-331  ASTM F2077-17      Withdrawn and
                                     Test Methods for   replaced with
                                     Intervertebral     newer version.
                                     Body Fusion
                                     Devices.
11-296............          11-332  ASTM F2193-18      Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     and Test Methods
                                     for Components
                                     Used in the
                                     Surgical
                                     Fixation of the
                                     Spinal Skeletal
                                     System.
11-297............          11-333  ASTM F382-17       Withdrawn and
                                     Standard           replaced with
                                     Specification      newer version.
                                     and Test Method
                                     for Metallic
                                     Bone Plates.
11-310............  ..............  ASTM F1611-00      Reaffirmation.
                                     (Reapproved
                                     2018) Standard
                                     Specification
                                     for
                                     Intramedullary
                                     Reamers.
11-315............          11-334  ASTM F1829-17      Withdrawn and
                                     Standard Test      replaced with
                                     Method for         newer version.
                                     Static
                                     Evaluation of
                                     Anatomic Glenoid
                                     Locking
                                     Mechanism in
                                     Shear.
11-318............          11-335  ASTM F3141-17a     Withdrawn and
                                     Standard Guide     replaced with
                                     for Total Knee     newer version.
                                     Replacement
                                     Loading Profiles.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-159............          16-202  ISO 7176-2 Third   Withdrawn and
                                     edition 2017-10    replaced with
                                     Wheelchairs--Par   newer version.
                                     t 2:
                                     Determination of
                                     dynamic
                                     stability of
                                     electric
                                     wheelchairs.
16-185............  ..............  ANSI RESNA WC-     Extent of
                                     2:2009 American    recognition.
                                     National
                                     Standard for
                                     Wheelchairs--Vol
                                     ume 2,
                                     Additional
                                     Requirements for
                                     Wheelchairs
                                     (including
                                     Scooters) with
                                     Electrical
                                     Systems Section
                                     21: Requirements
                                     and test methods
                                     for
                                     electromagnetic
                                     compatibility of
                                     electrically
                                     powered
                                     wheelchairs and
                                     motorized
                                     scooters.
16-193............          16-203  ASME A18.1-2017    Withdrawn and
                                     Safety Standard    replaced with
                                     for Platform       newer version.
                                     Lifts and
                                     Stairway
                                     Chairlifts.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-202............  ..............  IEC 60601-2-43     Recognition
                                     Edition 2.0 2010-  restored with
                                     03 Medical         transition
                                     electrical         period.
                                     equipment--Part
                                     2-43: Particular
                                     requirements for
                                     the safety and
                                     essential
                                     performance of X-
                                     ray equipment
                                     for
                                     interventional
                                     procedures.
12-204............  ..............  IEC 60601-2-28     Recognition
                                     Edition 2.0 2010-  restored with
                                     03 Medical         transition
                                     electrical         period.
                                     equipment--Part
                                     2-28: Particular
                                     requirements for
                                     the basic safety
                                     and essential
                                     performance of X-
                                     ray tube
                                     assemblies for
                                     medical
                                     diagnosis.
12-296............          12-317  IEC 60601-2-54     Withdrawn and
                                     CONSOLIDATED       replaced with
                                     VERSION Edition    newer version
                                     1.1 2015-04        including
                                     Medical            amendment.
                                     electrical
                                     equipment--Part
                                     2-54: Particular
                                     requirements for
                                     the basic safety
                                     and essential
                                     performance of X-
                                     ray equipment
                                     for radiography
                                     and radioscopy
                                     [Including:
                                     Amendment 2
                                     (2018)].
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-138............          14-512  ISO 13408-2        Withdrawn and
                                     Second edition     replaced with
                                     2018-01 Aseptic    newer version.
                                     processing of
                                     health care
                                     products--Part
                                     2: Sterilizing
                                     filtration.
14-275............  ..............  ANSI/AAMI          Reaffirmation.
                                     ST41:2008/
                                     (R)2018 Ethylene
                                     oxide
                                     sterilization in
                                     health care
                                     facilities:
                                     Safety and
                                     effectiveness.
14-293............  ..............  ANSI/AAMI          Reaffirmation.
                                     ST50:2004/
                                     (R)2018 Dry heat
                                     (heated air)
                                     sterilizers.
14-294............  ..............  ANSI/AAMI          Reaffirmation.
                                     ST40:2004/
                                     (R)2018 Table-
                                     top dry heat
                                     (heated air)
                                     sterilization
                                     and sterility
                                     assurance in
                                     health care
                                     facilities.
14-295............  ..............  ANSI/AAMI          Withdrawn. See 14-
                                     ST81:2004/         515.
                                     (R)2016
                                     Sterilization of
                                     medical devices--
                                     Information to
                                     be provided by
                                     the manufacturer
                                     for the
                                     processing of
                                     resterilizable
                                     medical devices.
14-344............          14-513  ASTM F2825-18      Withdrawn and
                                     Standard           replaced with
                                     Practice for       newer version.
                                     Climatic
                                     Stressing of
                                     Packaging
                                     Systems for
                                     Single Parcel
                                     Delivery.
14-407............          14-514  ISO 11737-1 Third  Withdrawn and
                                     edition 2018-01    replaced with
                                     Sterilization of   newer version.
                                     health care
                                     products--Microb
                                     iological
                                     methods--Part 1:
                                     Determination of
                                     a population of
                                     microorganisms
                                     on products.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.
\2\ Standards that are ``Withdrawn'' or ``Withdrawn and replaced with
  newer version'' will have a transition period with an expiration date
  as noted in the recognition database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.


[[Page 53269]]

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: 050.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-153.................  Standard Guide for Coating  ASTM F2743-11.
                         Inspection and Acute
                         Particulate
                         Characterization of
                         Coated Drug-Eluting
                         Vascular Stent Systems.
3-154.................  Standard Guide for Fatigue- ASTM F3211-17.
                         to-Fracture (FtF)
                         Methodology for
                         Cardiovascular Medical
                         Devices.
3-155.................  Medical electrical          IEC 60601-2-47
                         equipment--Part 2-47:       Edition 2.0 2012-
                         Particular requirements     02.
                         for the basic safety and
                         essential performance of
                         ambulatory
                         electrocardiographic
                         systems.
3-156.................  Implants for surgery--      ISO 14708-1 Second
                         Active implantable          edition 2014-08-15.
                         medical devices--Part 1:
                         General requirements for
                         safety, marking and for
                         information to be
                         provided by the
                         manufacturer.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-243.................  Corrosion Test Methods....  ANSI/ADA Standard
                                                     No. 97:2002/ISO
                                                     10271:2001
                                                     Reaffirmed by ANSI:
                                                     May 29, 2013.
4-244.................  Dentistry--Test methods     ISO 8325 Second
                         for rotary instruments.     edition 2004-09-15.
4-245.................  Dentistry--Corrosion test   ISO 10271 Second
                         methods for metallic        edition 2011-08-01.
                         materials.
4-246.................  Dentistry--Pre-capsulated   ISO 20749 First
                         dental amalgam.             edition 2017-03.
4-247.................  Dentistry--Laser welding    ISO 28319 Second
                         and filler materials.       edition 2018-04.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-118.................  Guidance for the creation   AAMI TIR66:2017.
                         of physiologic data and
                         waveform databases to
                         demonstrate reasonable
                         assurance of the safety
                         and effectiveness of
                         alarm system algorithms.
5-119.................  Medical devices--           ISO 18250-3 First
                         Connectors for reservoir    edition 2018-06.
                         delivery systems for
                         healthcare applications--
                         Part 3: Enteral
                         application.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-31.................  American National Standard  ANSI C63.15-2017
                         Recommended Practice for    (Revision of ANSI
                         the Immunity Measurement    C63.15-2016).
                         of Electrical and
                         Electronic Equipment.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-282.................  Performance Standards for   CLSI M60 1st
                         Antifungal Susceptibility   Edition.
                         Testing of Yeasts.
7-283.................  Essential Tools for         CLSI POCT04 3rd
                         Implementation and          Edition.
                         Management of a Point-of-
                         Care Testing Program.
7-284.................  Supplemental Tables for     CLSI EP37 1st
                         Interference Testing in     Edition.
                         Clinical Chemistry.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-479.................  Implants for surgery--      ISO 13781 Second
                         Homopolymers, copolymers    edition 2017-07.
                         and blends on
                         poly(lactide)--In vitro
                         degradation testing.
------------------------------------------------------------------------

[[Page 53270]]

 
                            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
------------------------------------------------------------------------
10-113................  American National Standard  ANSI Z80.30-2018.
                         for Ophthalmics--Toric
                         Intraocular Lenses.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-336................  Wear of implant materials-- ISO 17853 Third
                         Polymer and metal wear      edition 2011-03-01.
                         articles--Isolation and
                         characterization.
11-337................  Implants for surgery--      ISO 16087 First
                         Roentgen                    edition 2013-10-01.
                         stereophotogrammetric
                         analysis for the
                         assessment of migration
                         of orthopaedic implants.
11-338................  Implants for surgery--      ISO 11491 First
                         Determination of impact     edition 2017-07.
                         resistance of ceramic
                         femoral heads for hip
                         joint prostheses.
11-339................  Implants for surgery--      ISO 7206-2 Third
                         Partial and total hip       edition 2011-04-01
                         joint prostheses--Part 2:   AMENDMENT 1 2016-09-
                         Articulating surfaces       15.
                         made of metallic, ceramic
                         and plastics materials
                         [Including AMENDMENT1
                         (2016)].
11-340................  Standard Guide for          ASTM F3018-17.
                         Assessment of Hard-on-
                         Hard Articulation Total
                         Hip Replacement and Hip
                         Resurfacing Arthroplasty
                         Devices.
11-341................  Standard Test Method for    ASTM F3140-17.
                         Cyclic Fatigue Testing of
                         Metal Tibial Tray
                         Components of Unicondylar
                         Knee Joint Replacements.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-318................  Medical electrical          IEC 60601-2-64
                         equipment--Part 2-64:       Edition 1.0 2014-
                         Particular requirements     09.
                         for the basic safety and
                         essential performance of
                         light ion beam medical
                         electrical equipment.
12-319................  Medical electrical          IEC 60601-2-68
                         equipment--Part 2-68:       Edition 1.0 2014-
                         Particular requirements     09.
                         for the basic safety and
                         essential performance of
                         X-ray-based image-guided
                         radiotherapy equipment
                         for use with electron
                         accelerators, light ion
                         beam therapy equipment
                         and radionuclide beam
                         therapy equipment.
12-320................  Medical electrical          IEC 62667 Edition
                         equipment--Medical light    1.0 2017-08.
                         ion beam equipment--
                         Performance
                         characteristics.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-515................  Processing of health care   ISO 17664 Second
                         products--Information to    edition 2017-10.
                         be provided by the
                         medical device
                         manufacturer for the
                         processing of medical
                         devices.
14-516................  Standard Test Method for    ASTM F3039-15.
                         Detecting Leaks in
                         Nonporous Packaging or
                         Flexible Barrier
                         Materials by Dye
                         Penetration.
14-517................  Standard Guide for          ASTM F3293-18.
                         Application of Test Soils
                         for the Validation of
                         Cleaning Methods for
                         Reusable Medical Devices.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
15-55.................  Standard Guide for Micro-   ASTM F3259-17.
                         computed Tomography of
                         Tissue Engineered
                         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. Such 
standards are those that FDA has recognized by notice published in the 
Federal Register or that FDA has decided to recognize but for which 
recognition is pending (because a periodic notice has not yet

[[Page 53271]]

appeared in the Federal Register). FDA will announce additional 
modifications and revisions to the list of recognized consensus 
standards, as needed, in the Federal Register once a year, or more 
often if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
[email protected]. To be considered, such recommendations 
should contain, at a minimum, the following information available at 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22977 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P


