[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94388-94394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31008]
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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: 046
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: 046'' (Recognition List Number: 046), 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 December 23, 2016.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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: 046.'' 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 Division of Dockets
Management 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: 046.
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 046 is available on
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 046 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: 046'' 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,
standards@cdrh.fda.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
[[Page 94389]]
premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
Modifications to the initial list of recognized standards, as
published in the Federal Register, can be accessed at http://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. Both versions are
publicly accessible at the Agency's Internet site. See section VI of
this document for electronic access information. Interested persons
should review the supplementary information sheet for the standard to
understand fully the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 046
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. FDA
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA will use
the term ``Recognition List Number: 046'' to identify these 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
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Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
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A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-44............................. 1-117 ISO 5366 First edition 2016-10- Withdrawn and replaced with
01 Anaesthetic and respiratory newer version.
equipment--Tracheostomy tubes
and connectors.
1-93............................. 1-118 ISO 5361 Third edition 2016-09- Withdrawn and replaced with
01 Anaesthetic and respiratory newer version.
equipment--Tracheal tubes and
connectors.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-93............................. .............. ASTM F763-04 (Reapproved 2016) Reaffirmation.
Standard Practice for Short-
Term Screening of Implant
Materials.
2-94............................. .............. ASTM F981-04 (Reapproved 2016) Reaffirmation.
Standard Practice for
Assessment of Compatibility of
Biomaterials for Surgical
Implants with Respect to Effect
of Materials on Muscle and
Insertion into Bone.
2-126............................ 2-244 ASTM F748-16 Standard Practice Withdrawn and replaced with
for Selecting Generic newer version, Extent of
Biological Test Methods for recognition.
Materials and Devices.
2-134............................ .............. ASTM F2065-00 (Reapproved 2010) Withdrawn.
Standard Practice for Testing
for Alternative Pathway
Complement Activation in Serum
by Solid Materials.
2-189............................ .............. ASTM F895-11 (Reapproved 2016) Reaffirmation.
Standard Test Method for Agar
Diffusion Cell Culture
Screening for Cytotoxicity.
2-225............................ .............. ASTM F2567-06 (Reapproved 2010) Withdrawn.
Standard Practice for Testing
for Classical Complement
Activation in Serum by Solid
Materials.
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C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-58............................. .............. ANSI/AAMI/ISO 5840:2005/(R)2010 Withdrawn.
Cardiovascular implants--
Cardiac valve prostheses.
3-90............................. 3-144 ISO 7198 Second edition 2016-08- Withdrawn and replaced with
01 Cardiovascular implants and newer version.
extracorporeal systems--
Vascular prostheses--Tubular
vascular grafts and vascular
patches.
3-91............................. .............. ISO 5840 Fourth edition 2005-03- Withdrawn.
01 Cardiovascular implants--
Cardiac valve prostheses.
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D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
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5-79............................. 5-113 ASTM D7386-16 Standard Practice Withdrawn and replaced with
for Performance Testing of newer version.
Packages for Single Parcel
Delivery Systems.
5-87............................. .............. IEC 62366 Edition 1.1 2014-01 Transition.
Consolidated Version Medical
devices--Application of
usability engineering to
medical devices.
[[Page 94390]]
5-95............................. 5-114 IEC 62366-1 Edition 1.0 2015-02 Withdrawn and replaced with
Medical Devices--Part 1: newer version including
Application of Usability corrigendum.
Engineering to Medical Devices
[Including CORRIGENDUM 1
(2016)].
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F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
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.............. No modifications at this time ...........................
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G. General Hospital/General Plastic Surgery (GH/GPS)
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6-11............................. .............. ISO 594-1 First edition 1986-06- Transition.
15 Conical fittings with a 6%
(Luer) taper for syringes,
needles and certain other
medical equipment--Part 1:
General requirements.
6-129............................ .............. ISO 594-2 Second edition 1998-09- Transition.
01 Conical fittings with a 6%
(Luer) taper for syringes,
needles and certain other
medical equipment--Part 2: Lock
fittings.
6-165............................ .............. ASTM D6977-04 (Reapproved 2016) Reaffirmation.
Standard Specification for
Polychloroprene Examination
Gloves for Medical Application.
6-282............................ 6-383 ASTM D6499-16 Standard Test Withdrawn and replaced with
Method for The Immunological newer version.
Measurement of Antigenic
Protein in Natural Rubber and
its Products.
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H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-149............................ 7-267 CLSI C24 4th Edition Statistical Withdrawn and replaced with
Quality Control for newer version.
Quantitative Measurement
Procedures: Principles and
Definitions.
7-174............................ 7-268 CLSI EP21 2nd Edition Evaluation Withdrawn and replaced with
of Total Analytical Error for newer version, Extent of
Quantitative Medical Laboratory recognition.
Measurement Procedures.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-350............................ 8-435 ISO 5832-1 Fifth edition 2016-07- Withdrawn and replaced with
15 Implants for surgery-- newer version.
Metallic materials--Part 1:
Wrought stainless steel.
8-368............................ .............. ASTM F2625-10 (Reapproved 2016) Reaffirmation.
Standard Test Method for
Measurement of Enthalpy of
Fusion, Percent Crystallinity,
and Melting Point of Ultra-High-
Molecular Weight Polyethylene
by Means of Differential
Scanning Calorimetry.
8-376............................ .............. ASTM F2102-13 Standard Guide for Withdrawn. See 8-382.
Evaluating the Extent of
Oxidation in Ultra-High-
Molecular-Weight Polyethylene
Fabricated Forms Intended for
Surgical Implants.
8-384............................ 8-436 ASTM F2026-16 Standard Withdrawn and replaced with
Specification for newer version.
Polyetheretherketone (PEEK)
Polymers for Surgical Implant
Applications.
8-392............................ 8-437 ASTM F2082/F2082M-16 Standard Withdrawn and replaced with
Test Method for Determination newer version.
of Transformation Temperature
of Nickel-Titanium Shape Memory
Alloys by Bend and Free
Recovery.
8-407............................ 8-438 ISO/ASTM 52915 Second edition Withdrawn and replaced with
2016-02-15 Specification for newer version.
Additive Manufacturing File
Format (AMF) Version 1.2.
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J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
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.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-223........................... 11-311 ISO 14243-2 Third edition 2016- Withdrawn and replaced with
09-01 Implants for surgery-- newer version.
Wear of total knee-joint
prostheses--Part 2: Methods of
measurement.
[[Page 94391]]
11-225........................... 11-312 ISO 7206-4 Third edition 2010-06- Withdrawn and replaced with
15 Implants for surgery-- newer version including
Components for partial and amendment.
total knee joint prostheses--
Part 2: Articulating surfaces
made of metal, ceramic and
plastics materials [Including
AMENDMENT 1 (2016)].
11-231........................... 11-313 ISO 7207-2 Second edition 2011- Withdrawn and replaced with
07-01 Implants for surgery-- newer version including
Components for partial and amendment.
total knee joint prostheses--
Part 2: Articulating surfaces
made of metal, ceramic and
plastics materials [Including
AMENDMENT 1 (2016)].
11-249........................... 11-314 ISO 14242-2 Second edition 2016- Withdrawn and replaced with
09-15 Implants for surgery-- newer version.
Wear of total hip-joint
prostheses--Part 2: Methods of
measurement.
11-268........................... 11-315 ASTM F1829-16 Standard Test Withdrawn and replaced with
Method for Static Evaluation of newer version.
Anatomic Glenoid Locking
Mechanism in Shear.
11-287........................... .............. ASTM F382-14 Standard Withdrawn. See 11-297.
Specification and Test Method
for Metallic Bone Plates.
11-298........................... 11-316 ASTM F1264-16 Standard Withdrawn and replaced with
Specification and Test Methods newer version.
for Intramedullary Fixation
Devices.
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O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
.............. No modifications at this time ...........................
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-49............................ 12-303 IEC 61303 Edition 1.0 1994-09 Withdrawn and replaced with
Medical electrical equipment-- new version including
Radionuclide calibrators-- corrigendum.
Particular methods for
describing performance
[Including CORRIGENDUM 1
(2016)].
12-235........................... 12-304 IEC 60731 Edition 3.1 2016-04 Withdrawn and replaced with
Consolidated Version Medical newer version.
electrical equipment--
Dosimeters with ionization
chambers as used in
radiotherapy.
12-263........................... 12-305 ISO 13694 Second edition 2015-11- Withdrawn and replaced with
15 Optics and Photonics--Lasers newer version.
and laser-related equipment--
Test methods for laser beam
power (energy) density
distribution.
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Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-27............................ 13-85 CLSI AUTO11-A2 October 2014 Withdrawn and replaced with
Information Technology Security newer version.
of In Vitro Diagnostic
Instruments and Software
Systems; Approved Standard--
Second Edition.
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R. Sterility
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14-169........................... .............. ASTM F2391-05 (Reapproved 2016) Reaffirmation.
Standard Test Method for
Measuring Package and Seal
Integrity Using Helium as the
Tracer Gas.
14-197........................... 14-496 ASTM F1608-16 Standard Test Withdrawn and replaced with
Method for Microbial Ranking of newer version.
Porous Packaging Materials
(Exposure Chamber Method).
14-229........................... 14-497 ASTM F1980-16 Standard Guide for Withdrawn and replaced with
Accelerated Aging of Sterile newer version.
Barrier Systems for Medical
Devices.
14-285........................... .............. ANSI/AAMI/ISO 14161-2009/(R)2014 Reaffirmation.
Sterilization of health care
products--Biological
indicators--Guidance for the
selection, use and
interpretation of results.
14-311........................... .............. ANSI/AAMI ST55:2010/(R)2014 Reaffirmation.
Table-top steam sterilizers.
14-339........................... .............. ANSI/AAMI/ISO 20857:2010/(R)2015 Reaffirmation.
(Revision of ANSI/AAMI/
ST63:2002) Sterilization of
health care products--Dry heat--
Requirements for the
development, validation and
routine control of a
sterilization process for
medical devices.
14-349........................... .............. ANSI/AAMI/ISO 13408-3:2006/ Reaffirmation.
(R)2015 Aseptic processing of
health care products--Part 3:
Lyophilization.
14-360........................... .............. ANSI/AAMI ST72:2011/(R)2016 Reaffirmation.
Bacterial endotoxins--Test
methods, routine monitoring,
and alternatives to batch
testing.
14-453........................... 14-498 ASTM F2097-16 Standard Guide for Withdrawn and replaced with
Design and Evaluation of newer version.
Primary Flexible Packaging for
Medical Products.
14-462........................... 14-499 ASTM D4169-16 Standard Practice Withdrawn and replaced with
for Performance Testing of newer version.
Shipping Containers and Systems.
14-479........................... 14-500 ISO 14644-1 Second edition 2015- Withdrawn and replaced with
12-15 Cleanrooms and associated new recognition number.
controlled environments--Part
1: Classification of air
cleanliness by particle
concentration.
14-489........................... .............. USP 39-NF34:2016 Biological Withdrawn.
Indicator for Steam
Sterilization--Self Contained.
14-490........................... .............. USP 39-NF34:2016 Biological Withdrawn.
Indicator for Dry-Heat
Sterilization, Paper Carrier.
[[Page 94392]]
14-491........................... .............. USP 39-NF34:2016 Biological Withdrawn.
Indicator for Ethylene Oxide
Sterilization, Paper Carrier.
14-492........................... .............. USP 39-NF34:2016 Biological Withdrawn.
Indicator for Steam
Sterilization, Paper Carrier.
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S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-34............................ 15-48 ASTM F2605-16 Standard Test Withdrawn and replaced with
Method for Determining the newer version.
Molar Mass of Sodium Alginate
by Size Exclusion
Chromatography with Multi-angle
Light Scattering Detection (SEC-
MALS).
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\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: 046.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-119.................... Tracheal tubes designed ISO 14408 Third
for laser surgery-- edition 2016-02-
Requirements for 15.
marking and
accompanying
information.
1-120.................... Anaesthetic and ISO 18190 First
respiratory equipment-- edition 2016-11-
General requirements 01.
for airways and related
equipment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-245.................... Biological evaluation of ISO 10993-5 Third
medical devices--Part edition 2009-06-
5: Tests for in vitro 01.
cytotoxicity.
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C. Cardiovascular
------------------------------------------------------------------------
3-145.................... Cardiovascular implants-- ISO 5840-1:2015
Cardiac valve First edition 2015-
prostheses--Part 1: 09-15.
General requirements.
3-146.................... Cardiovascular implants-- ANSI/AAMI/ISO 5840-
Cardiac valve 1: 2015.
prostheses--Part 1:
General requirements.
3-147.................... Cardiovascular implants-- ISO 5840-2: 2015
Cardiac valve First edition 2015-
prostheses--Part 2: 09-15.
Surgically implanted
heart valve substitutes.
3-148.................... Cardiovascular implants-- ANSI/AAMI/ISO 5840-
Cardiac valve 2: 2015.
prostheses -- Part 2:
Surgically implanted
heart valve substitutes.
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D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-229.................... Medical electrical IEC 80601-2-60
equipment--Part 2-60: Edition 1.0 2012-
Particular requirements 02.
for the basic safety
and essential
performance of dental
equipment.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-115.................... Small-bore connectors ISO 80369-7 First
for liquids and gases edition 2016-10-
in healthcare 15.
applications--Part 7:
Connectors for
intravascular or
hypodermic applications.
5-116.................... Graphical symbols-- ISO 7010 Second
Safety colours and edition 2011-06-
safety signs-- 01.
Registered safety signs
[Including AMENDMENT 1
(2012) through
AMENDMENT 7 (2016)].
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-19.................... Medical electrical IEC TR 60601-4-2
equipment--Part 4-2: Edition 1.0 2016-
Guidance and 05.
interpretation--Electro
magnetic immunity:
Performance of medical
electrical equipment
and medical electrical
systems.
19-20.................... American National ANSI C63.16-2016
Standard Guide for (Revision of ANSI
Electrostatic Discharge C63.16-1993).
Test Methodologies and
Acceptance Criteria for
Electronic Equipment.
19-21.................... Medical Electrical AIM Standard Rev.
Equipment and System 1.00 2016-08-22.
Electromagnetic
Immunity Test for
Exposure to Radio
Frequency
Identification Readers--
An AIM Standard.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
[[Page 94393]]
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-269.................... Molecular Diagnostic CLSI MM23 1st
Methods for Solid Edition.
Tumors
(Nonhematological
Neoplasms).
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-439.................... Standard Specification ASTM F3001-14.
for Additive
Manufacturing Titanium-
6 Aluminum-4 Vanadium
ELI (Extra Low
Interstitial) with
Powder Bed Fusion.
8-440.................... Standard Specification ASTM F3091/F3091M-
for Powder Bed Fusion 14.
of Plastic Materials.
8-441.................... Standard Test Method for ASTM F3109-16.
Verification of Multi-
Axis Force Measuring
Platforms.
8-442.................... Standard Guide for ASTM F3127-16.
Validating Cleaning
Processes Used During
the Manufacture of
Medical Devices.
8-443.................... Standard Guide for ASTM F3160-16.
Metallurgical
Characterization of
Absorbable Metallic
Materials for Medical
Implants.
8-444.................... Additive manufacturing-- ISO 17296-2 First
General principles-- edition 2015-01-
Part 2: Overview of 15.
process categories and
feedstock.
8-445.................... Additive manufacturing-- ISO 17296-4 First
General principles-- edition 2014-09-
Part 4: Overview of 01.
data processing.
8-446.................... Standard Specification ASTM F2848-16.
for Medical-Grade Ultra-
High Molecular Weight
Polyethylene Yarns.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-317................... Standard Guide for ASTM F3129--16.
Characterization of
Material Loss from
Conical Taper Junctions
in Total Joint
Prostheses.
11-318................... Standard Guide for Total ASTM F3141--15.
Knee Replacement
Loading Profiles.
11-319................... Implants for surgery-- ISO 7206-12 First
Partial and total hip edition 2016-10-
joint prostheses--Part 01.
12: Deformation test
method for acetabular
shells.
11-320................... Implants for surgery-- ISO 7206-13 First
Partial and total hip edition 2016-07-
joint prostheses--Part 01.
13: Determination of
resistance to torque of
head fixation of
stemmed femoral
components..
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-199................... Wheelchairs Part 28: ISO 7176-28 First
Requirements and test edition 2012-10-1.
methods for
stairclimbing devices.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-86.................... Systems and software ISO/IEC 15026-1
engineering--Systems First edition 2013-
and software assurance-- 11-01.
Part 1: Concepts and
vocabulary.
13-87.................... Systems and software ISO/IEC 15026-2
engineering--Systems First edition 2011-
and software assurance-- 02-15.
Part 2: Assurance case.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
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.
[[Page 94394]]
IV. List of Recognized Standards
FDA maintains the Agency's current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate 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 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.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.
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
standards@cdrh.fda.gov. To be properly 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 address
of the national or international standards development organization,
(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.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. The Center for Devices and
Radiological Health (CDRH) maintains a site on the Internet for easy
access to information including text, graphics, and files that you may
download to a personal computer with access to the Internet. Updated on
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 046'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
Dated: December 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31008 Filed 12-22-16; 8:45 am]
BILLING CODE 4164-01-P