Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040, 48871-48879 [2015-19991]
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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 3, 2015, from 12:30
p.m. to 5 p.m., and November 4, 2015,
from 8 a.m. to 5 p.m.
Location: NCTR SAB, 3900 NCTR Rd.,
Conference rm. B–12, Jefferson, AR
72079. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Donna Mendrick,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
2208, Silver Spring, MD 20993–0002,
301–796–8892; or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On November 3, 2015, the
SAB Chair will welcome the
participants, and the NCTR Director will
provide a Center-wide update on
scientific initiatives and
accomplishments during the past year.
The SAB will be presented with an
overview of the Division of
Biochemistry Subcommittee and the
Subcommittee Site Visit Report.
Representatives from the Office of the
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Products and Tobacco will discuss
research needs and opportunities for
collaborations with NCTR.
On November 4, 2015, the Center for
Drug Evaluation and Research, Center
for Devices and Radiological Health,
Center for Biologics Evaluation and
Research, Center for Tobacco Products,
Center for Veterinary Medicine, and
Office of Regulatory Affairs will each
briefly discuss their Center-specific
research strategic needs. Following the
public session, the SAB will hear an
update from each of NCTR’s research
divisions.
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Following an open discussion of all
the information presented, the open
session of the meeting will close so the
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FDA intends to make background
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than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On November 3, 2015,
from 12:30 p.m. to 5 p.m., and
November 4, 2015, from 8 a.m. to 4:15
p.m., the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
October 27, 2015. Oral presentations
from the public will be scheduled
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12:45 p.m. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before October 19, 2015. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 20, 2015.
Closed Committee Deliberations: On
November 4, 2015, from 4:15 p.m. to 5
p.m., the meeting will be closed to
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would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussions of
information concerning individuals
associated with the research programs at
NCTR.
Persons attending FDA’s advisory
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access to electrical outlets.
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FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donna
Mendrick at least 7 days in advance of
the meeting.
FDA is committed to the orderly
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https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20051 Filed 8–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451; formerly
Docket No. 2004N–0226]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
040
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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: 040’’ (Recognition List
Number: 040), 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. See section VII for the
effective date of the recognition of
standards announced in this document.
ADDRESSES: An electronic copy of
Recognition List Number: 040 is
available on the Internet at https://
SUMMARY:
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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
VI for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 040
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:
040’’ to the Division of Industry and
Consumer Education, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149.
Submit electronic comments on this
document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3632, 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 (Pub. L. 105–115) amended section
514 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions or other requirements.
In 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
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 HTML and PDF
versions of the list of FDA Recognized
Consensus Standards. Both versions are
publicly accessible at the Agency’s
Internet site. See section VI 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: 040
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:
040’’ 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
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Anesthesia
1–46 ..................
1–103
1–82 ..................
........................
ISO 5367 Fifth edition 2014–10–15 Anaesthetic and respiratory equipment—Breathing sets and connectors.
IEC 60601–2–13 Edition 3.1 2009–08, Medical electrical equipment—
Part 2–13: Particular requirements for the safety and essential performance of anaesthetic systems.
Withdrawn and replaced
newer version.
Withdrawn. See 1–104.
with
B. Biocompatibility
2–220
2–208 ................
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2–179 ................
2–215
2–209 ................
2–216
2–210 ................
2–217
2–211 ................
2–218
2–212 ................
2–219
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ISO 10993–1 Fourth edition 2009–10–15 Biological evaluation of medical devices—Part 1:.
Evaluation and Testing within a risk management process [Including:
Technical Corrigendum 1 (2010)].
USP 38–NF33:2015 <87> Biological Reactivity Test, In Vitro—Direct
Contact Test.
USP 38–NF33:2015 <87> Biological Reactivity Test, In Vitro—Elution
Test.
USP 38–NF33:2015 <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample.
USP 38–NF33:2015 <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test.
USP 38–NF33:2015 <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test.
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Withdrawn and replaced with
newer version including Technical Corrigendum.
Withdrawn and
newer version.
Withdrawn and
newer version.
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newer version.
Withdrawn and
newer version.
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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
C. Cardiovascular
3–76 ..................
........................
3–117 ................
........................
3–122 ................
........................
ASTM F2129–08 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine The Corrosion Susceptibility of Small Implant Devices.
ANSI/AAMI/ISO 81060–2:2013 Non-invasive sphygmomanometers—
Part 2: Clinical validation of automated measurement type.
ISO 81060–2 Second edition 2013–05–01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type.
Transferred. See 8–177.
Extent of recognition.
Extent of recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4–105 ................
........................
4–130 ................
........................
4–150 ................
........................
4–184 ................
........................
4–191 ................
4–220
ANSI/ADA Standard No.75 (Reaffirmed by ANSI: September 8, 2014)
Resilient Lining Materials For Removable Dentures, Part 1: ShortTerm Materials.
ANSI/ADA Standard No. 17 (Reaffirmed by ANSI: September 8, 2014)
Denture Base Temporary Relining Resins.
ANSI/ADA Specification No. 19–2004/ISO 4823:2000 (Reaffirmed by
ANSI: October 6, 2014) Dental Elastomeric Impression Materials.
ANSI/ASA S3.25–2009 (Revision of ANSI S3.25–1989) (Reaffirmed by
ANSI September 11, 2014) American National Standard For an Occluded Ear Simulator.
ANSI/ASA S3.22–2014 AMERICAN NATIONAL STANDARD Specification of Hearing Aid Characteristics.
Reaffirmation.
Reaffirmation.
Reaffirmation.
Reaffirmation.
Withdrawn and
newer version.
replaced
with
E. General I (Quality Systems/Risk Management (QS/RM))
5–67 ..................
........................
5–87 ..................
........................
5–94 ..................
........................
ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of
usability engineering to medical devices.
IEC 62366 Edition 1.1 2014–01 Medical devices—Application of
usability engineering to medical devices.
AAMI/CN20 (PS):2014 Small-bore connectors for liquids and gases in
healthcare applications—Part 20: Common test methods.
Withdrawn. See 5–96.
Withdrawn. See 5–95.
Withdrawn. See 5–97.
F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
19–6 ..................
........................
IEC 60601–1–11 Edition 1.0 2010–04 Medical Electrical Equipment— Transition Period Added.
Part 1–11: General Requirements for Basic Safety and Essential
Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home
Healthcare Environment [Including: Technical Corrigendum 1 (2011)].
G. General Hospital/General Plastic Surgery (GH/GPS)
........................
6–185 ................
........................
6–200 ................
........................
6–274 ................
6–341
6–301 ................
........................
6–308 ................
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6–110 ................
6–342
6–326 ................
6–343
ASTM F1441–03 (Reapproved 2014) Standard Specification for SoftTissue Expander Devices.
ASTM F881¥94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants.
ASTM E1061–01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers.
ISO 11608–1 Third Edition 2014–12–15 Needle-based injection systems for medical use—Requirements and test methods—Part 1:
Needle-based injection systems.
ISO 10555–1 Second Edition 2013–07–01 Sterile, single-use
intravascular catheters—Part 1: General requirements.
IEC 80601–2–35 Edition 2.0 2009–10 Medical electrical equipment—
Part 2–35: Particular requirements for the basic safety and essential
performance of heating devices using blankets, pads or mattresses
and intended for heating in medical use [Including: Technical Corrigendum 1 (2012) and Technical Corrigendum 2 (2015)].
USP 38–NF 33:2015 Sodium Chloride Irrigation ....................................
6–327 ................
6–344
USP 38–NF 33:2015 Sodium Chloride Injection .....................................
6–328 ................
6–345
USP 38–NF33:2015 Nonabsorbable Surgical Suture .............................
6–329 ................
6–346
USP 38–NF33:2015 <881> Tensile Strength .........................................
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Reaffirmation.
Reaffirmation.
Reaffirmation.
Withdrawn and
newer version.
replaced
with
Extent of Recognition.
Withdrawn and replaced with
newer version including Technical Corrigendum.
Withdrawn and
newer version.
Withdrawn and
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Withdrawn and
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
6–330 ................
6–347
USP 38–NF33:2015 <861> Sutures—Diameter .....................................
6–331 ................
6–348
USP 38–NF33:2015 <871> Sutures—Needle Attachment .....................
6–332 ................
6–349
USP 38–NF33:2015 Sterile Water for Irrigation ......................................
6–333 ................
6–350
USP 38–NF33:2015 Heparin Lock Flush Solution ..................................
6–334 ................
6–351
USP 38–NF33:2015 Absorbable Surgical Suture ...................................
Withdrawn and
newer version.
Withdrawn and
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Withdrawn and
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Withdrawn and
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Withdrawn and
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replaced
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with
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replaced
with
replaced
with
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
H. In Vitro Diagnostics (IVD)
7–110 ................
7–251
7–143 ................
7–252
7–153 ................
7–253
7–230 ................
7–254
7–123 ................
7–255
7–247 ................
7–256
CLSI EP05–A3 Evaluation of Precision Performance of Quantitative
Measurement Methods; Approved Guideline-Third Edition.
CLSI EP14–A3 Evaluation of Matrix Effects; Approved Guideline—
Third Edition.
CLSI EP15–A3 User Verification of Performance for Precision and Estimation of Bias; Approved Guideline-Third Edition.
CLSI M07–A10 Methods for Dilution Antimicrobial Susceptibility Tests
for Bacteria that Grow Aerobically; Approved Standard—Ninth Edition.
CLSI MM09–A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition.
CLSI M100–S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement.
I. Materials
8–59 ..................
8–386
8–63 ..................
8–387
8–177 ................
........................
ISO 5832–4 Third edition 2014–09–15 Implants for surgery—Metallic
materials—Part 4: Cobalt-chromium-molybdenum casting alloy.
ISO 5832–11 Second edition 2014–09–15 Implants for surgery—Metallic materials—Part 11: Wrought titanium 6-aluminium 7-niobium
alloy.
ASTM F2129–08 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices.
Withdrawn and replaced newer
version.
Withdrawn and replaced with
newer version.
Updated to incorporate transferred
recognitions 3–76 and 17–9.
J. Neurology
17–9 ..................
........................
17–4 ..................
........................
ASTM F2129–08 Standard Test Method for Conducting Cyclic
Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices.
ASTM F647–94(2014) Standard Practice for Evaluating and Specifying
Implantable Shunt Assemblies for Neurosurgical Application.
Transferred. See 8–177.
Reaffirmation.
K. Obstetrics-Gynecology-Urology-Gastroenterology (OB–GYN–GU)/Gastroenterology
9–104
9–97 ..................
........................
9–69 ..................
9–105
9–100 ................
........................
9–71 ..................
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9–73 ..................
9–106
9–70 ..................
9–107
9–102 ................
........................
9–90 ..................
9–108
9–56 ..................
9–109
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ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapies.
ISO 13958 Third edition 2014–04–01 Concentrates for haemodialysis
and related therapies.
ANSI/AAMI 13959:2014 Water for hemodialysis and related therapies
ISO 11663 Second edition 2014–04–01 Quality of dialysis fluid for
haemodialysis and related therapies.
ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis
and related therapies.
ANSI/AAMI 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies.
ISO 4074 Second edition 2014–08–15 Natural latex rubber condoms—
Requirements and test methods.
ISO 8009 Second edition 2014–11–15 Mechanical contraceptives—
Reusable natural and silicone rubber contraceptive diaphragms—
Requirements and tests.
ASTM D3492–08 Standard Specification for Rubber Contraceptives
(Male Condoms).
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Withdrawn and replaced
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Extent of recognition.
with
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Extent of recognition.
with
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Extent of recognition.
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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
L. Ophthalmic
10–29 ................
10–94
10–55 ................
10–95
10–62 ................
10–96
10–68 ................
10–97
10–82 ................
10–98
ISO 14730 Second edition 2014–10–01 Ophthalmic Optics—Contact
lens care products—antimicrobial preservative efficacy testing and
guidance on determining discard date.
ISO 11979–6 Third edition 2014–10–01 Ophthalmic implants—intraocular lenses—Part 6: Shelf-life and transport stability.
ANSI Z80.10–2014 American National Standard for Opthalmics Ophthalmic Instruments—Tonometers.
ISO 13212 Third edition 2014–09–01 Ophthalmic Optics-Contact lens
care products—Guidelines for determination of shelf-life.
ISO 11979–2 Second edition 2014–08–15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methods.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
replaced
with
replaced
with
M. Orthopedic
11–240 ..............
11–287
11–235 ..............
11–288
11–207 ..............
11–289
11–183 ..............
........................
11–266 ..............
........................
11–224 ..............
........................
11–80 ................
11–290
11–248 ..............
11–291
11–250 ..............
11–292
ASTM F382–14 Standard Specification and Test Method for Metallic
Bone Plates.
ASTM F2077–14 Test Methods for Intervertebral Body Fusion Devices
ASTM F2193–14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
ASTM F1875–98 (Reapproved 2014) Standard Practice for Fretting
Corrosion Testing of Modular Implant Interfaces: Hip Femoral HeadBore and Cone Taper Interface.
ASTM F2665–09 (Reapproved 2014) Standard Specification for Total
Ankle Replacement Prosthesis.
ASTM F2706–08 (Reapproved 2014) Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model..
ISO 8828 Second edition 2014–11–15 Implants for surgery—Guidance
on Care and Handling of Orthopaedic Implants.
ISO 14242–1 Third edition 2014–10–15 Implants for surgery—Wear of
total hip-joint prostheses—Part 1: Loading and displacement parameters for wear testing machines and corresponding environmental
conditions for test.
ISO 14243–3 Second edition 2014–11–01 Implants for surgery—Wear
of total knee prostheses—Part 3: Loading and displacement parameters for wear—testing machines with displacement control and corresponding environmental conditions for test.
Withdrawn and replaced newer
version.
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version.
Reaffirmation.
Reaffirmation.
Reaffirmation.
Withdrawn and
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with
N. Radiology
12–102 ..............
........................
12–212 ..............
12–289
12–229 ..............
12–290
12–278 ..............
12–291
ANSI/IESNA RP–27.2–2000 (Reaffirmed 2011) Photobiological Safety
for Lamp & Lamp Systems-Measurement Techniques.
IEC 62220–1–1 Edition 1.0 2015–03 Medical electrical equipment—
Characteristics of digital x-ray imaging devices—Part 1–1: Determination of the detective quantum efficiency—Detectors used in radiographic imaging.
IEC 61910–1 Edition 1.0 2014–09 Medical electrical equipment—Radiation dose documentation—Part 1: Radiation dose structured reports for radiography and radioscopy.
IEC 62127–2 Edition 1.1 2013–02 Ultrasonics Hydrophones—Part 2:
Calibration for ultrasonic fields up to 40 MHz.
Reaffirmation.
O. Sterility
asabaliauskas on DSK5VPTVN1PROD with NOTICES
14–193 ..............
14–457
14–194 ..............
14–458
14–195 ..............
14–459
14–287 ..............
........................
VerDate Sep<11>2014
18:50 Aug 13, 2015
ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile
barrier systems and packaging [Including: Amendment 1 (2014)].
ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming,
sealing and assembly processes[Including: Amendment 1 (2014)].
ANSI/AAMI/ISO 11140–1:2014 Sterilization of health care products—
Chemical indicators—Part 1: General requirements.
ANSI/AAMI/ISO 11737–2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization process.
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Withdrawn and replaced with
newer version including Amendment.
Withdrawn and replaced with
newer version including Amendment.
Withdrawn and replaced with
newer version.
Reaffirmation.
14AUN1
48876
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
Withdrawn and replaced with
newer version including Amendment.
14–297 ..............
14–461
14–300 ..............
14–462
14–327 ..............
........................
14–350 ..............
........................
14–353 ..............
14–460
14–391 ..............
14–463
14–392 ..............
14–464
14–431 ..............
14–465
14–440 ..............
14–466
14–441 ..............
14–467
ANSI/AAMI/ISO 11137–1:2006/(R) 2010 Sterilization Of Health Care
Products—Radiation—Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical
Devices [Including: Amendment 1 (2013)].
ASTM D4169—14 Standard Practice for Performance Testing of Shipping Containers and Systems.
ISO 11737–2 Second edition 2009–11–15 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization process.
ANSI/AAMI/ISO 13408–4:2005/(R)2014, Aseptic processing of health
care products—Part 4: Clean-in-place technologies.
ISO 11140–1 Third edition 2014–11–01 Sterilization of health care
products—Chemical indicators—Part 1: General requirements.
ISO/ASTM 51608 Third edition 2015–03–15 Practice for dosimetry in
an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV.
ISO/ASTM 51649 Third edition 2015–03–15 Practice for dosimetry in
an electron beam facility for radiation processing at energies between 300 keV and 25 MeV.
ISO/ASTM 51707 Third edition 2015–03–15 Guide for estimation of
measurement uncertainty in dosimetry for radiation processing.
USP 38–NF33:2015 <61> Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests.
USP 38–NF33:2015 <71> Sterility Tests ................................................
14–442 ..............
14–468
USP 38–NF33:2015 <85> Bacterial Endotoxins Test .............................
14–443 ..............
14–477
USP 38–NF33:2015 <151> Pyrogen Test (USP Rabbit Test) ...............
14–444 ..............
14–469
14–445 ..............
14–470
14–446 ..............
14–471
14–447 ..............
14–472
14–448 ..............
14–473
14–449 ..............
14–474
14–450 ..............
14–475
14–451 ..............
14–476
USP 38–NF33:2015 <161> Transfusion and Infusion Assemblies and
Similar Medical Devices.
USP 38–NF33:2015 Biological Indicator for Steam Sterilization—Self
Contained.
USP 38–NF33:2015 Biological Indicator for Dry-Heat Sterilization,
Paper Carrier.
USP 38–NF33:2015 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier.
USP 38–NF33:2015 Biological Indicator for Steam Sterilization, Paper
Carrier.
USP 38–NF33:2015 <62> Microbiological Examination of Nonsterile
Products: Tests for Specified Microorganisms.
USP 38–NF33:2015 <55> Biological Indicators—Resistance Performance Tests.
USP 38–NF33:2015 <1035> Biological Indicators for Sterilization ........
1 All
Withdrawn and replaced
newer version.
Extent of Recognition.
with
Reaffirmation.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
replaced
with
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: 040.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
asabaliauskas on DSK5VPTVN1PROD with NOTICES
A. Anesthesia
1–104 .................
1–105 .................
VerDate Sep<11>2014
Medical electrical equipment—Part 2–13: Particular Requirements for basic safety
and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)].
Medical electrical equipment—Part 2–72: Particular requirements for basic safety
and essential performance of home healthcare environment ventilators for ventilator-dependent patients.
18:50 Aug 13, 2015
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ISO 80601–2–13 First Edition 2011–08–
01 and Amendment 1 2015.
ISO 80601–2–72 First Edition 2015–04–
11.
14AUN1
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48877
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
B. Biocompatibility
2–221 .................
2–222 .................
Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements ..
Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements ..
ANSI/AAMI/ISO 10993–2:2006 (R2014).
ISO 10993–2 Second edition 2006–07–
15.
C. Cardiovascular
3–135 .................
3–136 .................
3–137 .................
3–138 .................
3–139 .................
Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products.
Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products.
Standard Guide for Testing Absorbable Stents ........................................................
Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of
Vascular Stents.
Active implantable medical devices—Electromagnetic compatibility—EMC test
protocols for implantable cardiac pacemakers, implantable cardioverter
defibrillators and cardiac resynchronization devices.
ISO/TS 12417–1 First edition 2011–06–
01.
ANSI/AAMI/ISO TIR12417:2011.
ASTM F3036–13.
ASTM F2942–13.
ISO 14117 First edition 2012–07–15.
D. General I (Quality Systems/Risk Management)
5–95 ...................
5–96 ...................
5–97 ...................
Medical devices—Part 1: Application of usability engineering to medical devices ..
Medical devices—Part 1: Application of usability engineering to medical devices ..
Small-bore connectors for liquids and gases in healthcare applications—Part 20:
Common test methods.
IEC 62366–1 Edition 1.0 2015–02.
ANSI/AAMI/IEC 62366–1:2015.
ISO 80369–20 First edition 2015–05–15.
E. General II (ES/EMC)
19–14 .................
19–15 .................
Medical electrical equipment—Part 1–11: General requirements for basic safety
and essential performance—Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment.
Medical electrical equipment—Part 1–12: General requirements for basic safety
and essential performance—Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the
emergency medical services environment.
IEC 60601–1–11 Edition 2.0 2015–01.
IEC 60601–1–12 Edition 1.0 2014–06.
F. GH/GPS
6–352 .................
6–353 .................
6–354 .................
Standard Specification for Implantable Breast Prostheses .......................................
Standard Specification for Implantable Saline Filled Breast Prosthesis ...................
Standard Specification for Radiation Attenuating Protective Gloves ........................
ASTM F703–07.
ASTM F2051¥00 (Reapproved 2014).
ASTM D7866–14.
G. IVD
7–257 .................
7–258 .................
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline.
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved
Standards- Twelfth Edition.
CLSI M56–A.
CLSI M02–A12.
H. Materials
8–388 .................
8–389 .................
8–390 .................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
8–391 .................
Implants for surgery—Ceramic materials—Part 2: Composite materials based on
a high-purity alumina matrix with zirconia reinforcement.
Implants for surgery—Differential scanning calorimetry of poly ether ether ketone
(PEEK) polymers and compounds for use in implantable medical devices.
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer
Resins for Surgical Implants.
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for
Surgical Implants with Mole Fractions Greater Than or Equal To 70% Glycolide.
ISO 6474–2 First edition 2012–04–15.
ISO 15309 First edition 2013–12–01.
ASTM F1925–09.
ASTM F2313–10.
I. Nanotechnology
18–4 ...................
Technical Specification—Nanotechnologies—Vocabulary—Part 6: Nano-object
characterization.
ISO/TS 80004–6 First edition 2013–11–
01.
J. Neurology
17–14 .................
VerDate Sep<11>2014
Transcutaneous electrical nerve stimulators .............................................................
18:50 Aug 13, 2015
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ANSI/AAMI NS4:2013.
14AUN1
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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
K. OB–GYN–GU/Gastroenterology
9–103 .................
Water treatment equipment for hemodialysis and related therapies ........................
ANSI/AAMI 26722:2014.
L. Ophthalmic
10–99 .................
Anionic and non-ionic surface active agents—Determination of critical
micellization concentration—Method by measuring surface tension with a plate,
stirrup, or ring,.
ISO 4311 First edition 1979–06–01.
M. Orthopedic
11–293 ...............
11–294 ...............
11–295 ...............
Standard Test Method for Impingement of Acetabular Prostheses ..........................
Standard Specification for Articulating Total Wrist Implants .....................................
Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis.
ASTM F2582–14.
ASTM F1357–14.
ASTM F2580–13.
N. Physical Medicine
16–194 ...............
Wheelchairs Part 25:Batteries and chargers for powered wheelchairs ....................
ISO 7176–25 First edition 2013–07–15.
O. Radiology
12–292 ...............
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling ........
IEEE Std 3333.2.1–2015.
P. Software/Informatics
13–73 .................
Systematized Nomenclature of Medicine—Clinical Terms .......................................
13–74 .................
13–77 .................
Health informatics—Personal health device communication, Part 10424: Device
Specialization—Sleep Apnoea Breathing Therapy Equipment (SABTE).
Health informatics—Point-of-care medical device communication—Part 10102:
Nomenclature—Annotated ECG.
Health informatics—Standard communication protocol—Part 91064: Computer-assisted electrocardiography.
Information technology—Security techniques—Vulnerability disclosure ..................
13–78 .................
Information technology—Security techniques—Vulnerability handling processes ...
13–75 .................
13–76 .................
IHTSDO SNOME–CT RF2
2015.
IEEE Std 11073–10424–2014.
Release
ISO/IEEE 11073–10102 First edition
2014–03–01.
ISO 11073–91064 First edition 2009–
05–01.
ISO/IEC 29147 First edition 2014–02–
15.
ISO/IEC 30111 First edition 2013–11–
01.
Q. Sterility
14–478 ...............
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1 All
Flexible and semi-rigid endoscope processing in health care facilities ....................
ANSI/AAMI ST91:2015.
standard titles in this table conform to the style requirements of the respective organizations.
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 https://
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,
VerDate Sep<11>2014
18:50 Aug 13, 2015
Jkt 235001
processes affected, Code of Federal
Regulations citations, and product
codes.
V. Recommendation of Standards for
Recognition by FDA
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
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
PO 00000
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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, https://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
E:\FR\FM\14AUN1.SGM
14AUN1
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Notices
Recognized Standards, Recognition List
Number: 040’’ will be available at https://
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
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
VII. Submission of Comments and
Effective Date
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov. 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:
040. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–19991 Filed 8–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0386]
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection
and Differentiation of Human
Papillomaviruses; Draft Guidance for
Industry and Food and Drug
Administration Staff: Availability
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for the Detection or Detection
and Differentiation of Human
SUMMARY:
VerDate Sep<11>2014
18:50 Aug 13, 2015
Jkt 235001
Papillomaviruses.’’ This draft guidance
provides recommendations to facilitate
study designs to establish the
performance characteristics of in vitro
diagnostic devices (IVDs) intended for
the detection, or detection and
differentiation, of human
papillomaviruses (HPVs). This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance November 12,
2015.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or
Detection and Differentiation of Human
Papillomaviruses’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Natalia Comella, Center for Devices and
Radiological Health, Food and Drug
Administration, New Hampshire Ave.,
Bldg. 66, Rm. 4536, Silver Spring, MD
20993–0002, 301–796–6226,
Natalia.Comella@fda.hhs.gov, or Marina
V. Kondratovich, Center for Devices and
Radiological Health, Food and Drug
Administration, New Hampshire Ave.,
Bldg. 66, Rm. 4672, Silver Spring, MD
20993–0002, 301–796–6036,
Marina.Kondratovich@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides
recommendations to facilitate study
designs to establish the performance
PO 00000
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48879
characteristics of IVDs intended for the
detection, or detection and
differentiation, of HPVs. These devices
are used either in conjunction with
cervical cytology to aid in screening for
cervical cancer or as first-line primary
cervical cancer screening devices. These
devices include those that detect a
group of HPV genotypes, particularly
high risk HPVs, as well as devices that
detect more than one genotype of HPV
and further differentiate among them to
indicate which genotype of HPV is
present or which genotypes of HPV are
present.
When finalized, this draft guidance is
expected to provide detailed
information on the types of studies the
FDA recommends to support a
premarket application for these devices.
This draft guidance specifically
addresses devices that qualitatively
detect HPV nucleic acid from cervical
specimens, but many of the
recommendations will also be
applicable to devices that detect HPV
proteins. The draft guidance is limited
to studies intended to establish the
performance characteristics of in vitro
diagnostic HPV devices that are used in
conjunction with cervical cytology for
cancer screening or as first-line primary
cervical cancer screening devices. This
draft guidance does not address HPV
testing from non-cervical specimens
such as pharyngeal, vaginal, penile, or
anal specimens, or testing for
susceptibility to HPV infection. It does
not address quantitative or semiquantitative assays for HPV.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on evaluating the performance
characteristics of IVDs intended for the
detection, or detection and
differentiation, of HPVs. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48871-48879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19991]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451; formerly Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 040
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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: 040'' (Recognition List Number: 040), 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. See section VII for the effective date of the recognition
of standards announced in this document.
ADDRESSES: An electronic copy of Recognition List Number: 040 is
available on the Internet at https://
[[Page 48872]]
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/
ucm123792.htm. See section VI for electronic access to the searchable
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 040 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: 040'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149.
Submit electronic comments on this document to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, 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 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section
514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In 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 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 HTML and PDF
versions of the list of FDA Recognized Consensus Standards. Both
versions are publicly accessible at the Agency's Internet site. See
section VI 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: 040
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: 040'' 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
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-46............................. 1-103 ISO 5367 Fifth edition 2014-10- Withdrawn and replaced with
15 Anaesthetic and respiratory newer version.
equipment--Breathing sets and
connectors.
1-82............................. .............. IEC 60601-2-13 Edition 3.1 2009- Withdrawn. See 1-104.
08, Medical electrical
equipment--Part 2-13:
Particular requirements for the
safety and essential
performance of anaesthetic
systems.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-179............................ 2-220 ISO 10993-1 Fourth edition 2009- Withdrawn and replaced with
10-15 Biological evaluation of newer version including
medical devices--Part 1:. Technical Corrigendum.
Evaluation and Testing within a
risk management process
[Including: Technical
Corrigendum 1 (2010)].
2-208............................ 2-215 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Direct Contact Test.
2-209............................ 2-216 USP 38-NF33:2015 <87> Biological Withdrawn and replaced with
Reactivity Test, In Vitro-- newer version.
Elution Test.
2-210............................ 2-217 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo, newer version.
Procedure Preparation of Sample.
2-211............................ 2-218 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Test, In Vitro, newer version.
Classification of Plastics--
Intracutaneous Test.
2-212............................ 2-219 USP 38-NF33:2015 <88> Biological Withdrawn and replaced with
Reactivity Tests, In Vivo, newer version.
Classification of Plastics--
Systemic Injection Test.
----------------------------------------------------------------------------------------------------------------
[[Page 48873]]
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-76............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177.
Method for Conducting Cyclic
Potentiodynamic Polarization
Measurements to Determine The
Corrosion Susceptibility of
Small Implant Devices.
3-117............................ .............. ANSI/AAMI/ISO 81060-2:2013 Non- Extent of recognition.
invasive sphygmomanometers--
Part 2: Clinical validation of
automated measurement type.
3-122............................ .............. ISO 81060-2 Second edition 2013- Extent of recognition.
05-01 Non-invasive
sphygmomanometers--Part 2:
Clinical validation of
automated measurement type.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105............................ .............. ANSI/ADA Standard No.75 Reaffirmation.
(Reaffirmed by ANSI: September
8, 2014) Resilient Lining
Materials For Removable
Dentures, Part 1: Short-Term
Materials.
4-130............................ .............. ANSI/ADA Standard No. 17 Reaffirmation.
(Reaffirmed by ANSI: September
8, 2014) Denture Base Temporary
Relining Resins.
4-150............................ .............. ANSI/ADA Specification No. 19- Reaffirmation.
2004/ISO 4823:2000 (Reaffirmed
by ANSI: October 6, 2014)
Dental Elastomeric Impression
Materials.
4-184............................ .............. ANSI/ASA S3.25-2009 (Revision of Reaffirmation.
ANSI S3.25-1989) (Reaffirmed by
ANSI September 11, 2014)
American National Standard For
an Occluded Ear Simulator.
4-191............................ 4-220 ANSI/ASA S3.22-2014 AMERICAN Withdrawn and replaced with
NATIONAL STANDARD Specification newer version.
of Hearing Aid Characteristics.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-67............................. .............. ANSI/AAMI/IEC 62366:2007/(R)2013 Withdrawn. See 5-96.
Medical devices--Application of
usability engineering to
medical devices.
5-87............................. .............. IEC 62366 Edition 1.1 2014-01 Withdrawn. See 5-95.
Medical devices--Application of
usability engineering to
medical devices.
5-94............................. .............. AAMI/CN20 (PS):2014 Small-bore Withdrawn. See 5-97.
connectors for liquids and
gases in healthcare
applications--Part 20: Common
test methods.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
----------------------------------------------------------------------------------------------------------------
19-6............................. .............. IEC 60601-1-11 Edition 1.0 2010- Transition Period Added.
04 Medical Electrical
Equipment--Part 1-11: General
Requirements for Basic Safety
and Essential Performance--
Collateral Standard:
Requirements for Medical
Electrical Equipment and
Medical Electrical Systems used
in the Home Healthcare
Environment [Including:
Technical Corrigendum 1 (2011)].
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-110............................ .............. ASTM F1441-03 (Reapproved 2014) Reaffirmation.
Standard Specification for Soft-
Tissue Expander Devices.
6-185............................ .............. ASTM F881-94 (Reapproved 2014) Reaffirmation.
Standard Specification for
Silicone Elastomer Facial
Implants.
6-200............................ .............. ASTM E1061-01 (Reapproved 2014) Reaffirmation.
Standard Specification for
Direct-Reading Liquid Crystal
Forehead Thermometers.
6-274............................ 6-341 ISO 11608-1 Third Edition 2014- Withdrawn and replaced with
12-15 Needle-based injection newer version.
systems for medical use--
Requirements and test methods--
Part 1: Needle-based injection
systems.
6-301............................ .............. ISO 10555-1 Second Edition 2013- Extent of Recognition.
07-01 Sterile, single-use
intravascular catheters--Part
1: General requirements.
6-308............................ 6-342 IEC 80601-2-35 Edition 2.0 2009- Withdrawn and replaced with
10 Medical electrical newer version including
equipment--Part 2-35: Technical Corrigendum.
Particular requirements for the
basic safety and essential
performance of heating devices
using blankets, pads or
mattresses and intended for
heating in medical use
[Including: Technical
Corrigendum 1 (2012) and
Technical Corrigendum 2 (2015)].
6-326............................ 6-343 USP 38-NF 33:2015 Sodium Withdrawn and replaced with
Chloride Irrigation. newer version.
6-327............................ 6-344 USP 38-NF 33:2015 Sodium Withdrawn and replaced with
Chloride Injection. newer version.
6-328............................ 6-345 USP 38-NF33:2015 Nonabsorbable Withdrawn and replaced with
Surgical Suture. newer version.
6-329............................ 6-346 USP 38-NF33:2015 <881> Tensile Withdrawn and replaced with
Strength. newer version.
[[Page 48874]]
6-330............................ 6-347 USP 38-NF33:2015 <861> Sutures-- Withdrawn and replaced with
Diameter. newer version.
6-331............................ 6-348 USP 38-NF33:2015 <871> Sutures-- Withdrawn and replaced with
Needle Attachment. newer version.
6-332............................ 6-349 USP 38-NF33:2015 Sterile Water Withdrawn and replaced with
for Irrigation. newer version.
6-333............................ 6-350 USP 38-NF33:2015 Heparin Lock Withdrawn and replaced with
Flush Solution. newer version.
6-334............................ 6-351 USP 38-NF33:2015 Absorbable Withdrawn and replaced with
Surgical Suture. newer version.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-110............................ 7-251 CLSI EP05-A3 Evaluation of Withdrawn and replaced with
Precision Performance of newer version.
Quantitative Measurement
Methods; Approved Guideline-
Third Edition.
7-143............................ 7-252 CLSI EP14-A3 Evaluation of Withdrawn and replaced with
Matrix Effects; Approved newer version.
Guideline--Third Edition.
7-153............................ 7-253 CLSI EP15-A3 User Verification Withdrawn and replaced with
of Performance for Precision newer version.
and Estimation of Bias;
Approved Guideline-Third
Edition.
7-230............................ 7-254 CLSI M07-A10 Methods for Withdrawn and replaced with
Dilution Antimicrobial newer version.
Susceptibility Tests for
Bacteria that Grow Aerobically;
Approved Standard--Ninth
Edition.
7-123............................ 7-255 CLSI MM09-A2 Nucleic Acid Withdrawn and replaced with
Sequencing Methods in newer version.
Diagnostic Laboratory Medicine;
Approved Guideline--Second
Edition.
7-247............................ 7-256 CLSI M100-S25 Performance Withdrawn and replaced with
Standards for Antimicrobial newer version.
Susceptibility Testing; Twenty-
Fifth Informational Supplement.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-59............................. 8-386 ISO 5832-4 Third edition 2014-09- Withdrawn and replaced
15 Implants for surgery-- newer version.
Metallic materials--Part 4:
Cobalt-chromium-molybdenum
casting alloy.
8-63............................. 8-387 ISO 5832-11 Second edition 2014- Withdrawn and replaced with
09-15 Implants for surgery-- newer version.
Metallic materials--Part 11:
Wrought titanium 6-aluminium 7-
niobium alloy.
8-177............................ .............. ASTM F2129-08 Standard Test Updated to incorporate
Method for Conducting Cyclic transferred recognitions 3-
Potentiodynamic Polarization 76 and 17-9.
Measurements to Determine the
Corrosion Susceptibility of
Small Implant Devices.
----------------------------------------------------------------------------------------------------------------
J. Neurology
----------------------------------------------------------------------------------------------------------------
17-9............................. .............. ASTM F2129-08 Standard Test Transferred. See 8-177.
Method for Conducting Cyclic
Potentiodynamic Polarization
Measurements to Determine the
Corrosion Susceptibility of
Small Implant Devices.
17-4............................. .............. ASTM F647-94(2014) Standard Reaffirmation.
Practice for Evaluating and
Specifying Implantable Shunt
Assemblies for Neurosurgical
Application.
----------------------------------------------------------------------------------------------------------------
K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-73............................. 9-104 ANSI/AAMI/ISO 13958:2014 Withdrawn and replaced with
Concentrates for hemodialysis newer version.
and related therapies.
9-97............................. .............. ISO 13958 Third edition 2014-04- Extent of recognition.
01 Concentrates for
haemodialysis and related
therapies.
9-69............................. 9-105 ANSI/AAMI 13959:2014 Water for Withdrawn and replaced with
hemodialysis and related newer version.
therapies.
9-100............................ .............. ISO 11663 Second edition 2014-04- Extent of recognition.
01 Quality of dialysis fluid
for haemodialysis and related
therapies.
9-71............................. 9-106 ANSI/AAMI/ISO 11663:2014 Quality Withdrawn and replaced with
of dialysis fluid for newer version.
hemodialysis and related
therapies.
9-70............................. 9-107 ANSI/AAMI 23500:2014 Guidance Withdrawn and replaced with
for the preparation and quality newer version.
management of fluids for
hemodialysis and related
therapies.
9-102............................ .............. ISO 4074 Second edition 2014-08- Extent of recognition.
15 Natural latex rubber
condoms--Requirements and test
methods.
9-90............................. 9-108 ISO 8009 Second edition 2014-11- Withdrawn and replaced with
15 Mechanical contraceptives-- newer version.
Reusable natural and silicone
rubber contraceptive
diaphragms--Requirements and
tests.
9-56............................. 9-109 ASTM D3492-08 Standard Withdrawn and replaced with
Specification for Rubber newer version.
Contraceptives (Male Condoms).
----------------------------------------------------------------------------------------------------------------
[[Page 48875]]
L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-29............................ 10-94 ISO 14730 Second edition 2014-10- Withdrawn and replaced with
01 Ophthalmic Optics--Contact newer version.
lens care products--
antimicrobial preservative
efficacy testing and guidance
on determining discard date.
10-55............................ 10-95 ISO 11979-6 Third edition 2014- Withdrawn and replaced with
10-01 Ophthalmic implants-- newer version.
intraocular lenses--Part 6:
Shelf-life and transport
stability.
10-62............................ 10-96 ANSI Z80.10-2014 American Withdrawn and replaced with
National Standard for newer version.
Opthalmics Ophthalmic
Instruments--Tonometers.
10-68............................ 10-97 ISO 13212 Third edition 2014-09- Withdrawn and replaced with
01 Ophthalmic Optics-Contact newer version.
lens care products--Guidelines
for determination of shelf-life.
10-82............................ 10-98 ISO 11979-2 Second edition 2014- Withdrawn and replaced with
08-15 Ophthalmic implants-- newer version.
Intraocular lenses--Part 2:
Optical properties and test
methods.
----------------------------------------------------------------------------------------------------------------
M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-240........................... 11-287 ASTM F382-14 Standard Withdrawn and replaced
Specification and Test Method newer version.
for Metallic Bone Plates.
11-235........................... 11-288 ASTM F2077-14 Test Methods for Withdrawn and replaced with
Intervertebral Body Fusion newer version.
Devices.
11-207........................... 11-289 ASTM F2193-14 Standard Withdrawn and replaced with
Specifications and Test Methods newer version.
for Components Used in the
Surgical Fixation of the Spinal
Skeletal System.
11-183........................... .............. ASTM F1875-98 (Reapproved 2014) Reaffirmation.
Standard Practice for Fretting
Corrosion Testing of Modular
Implant Interfaces: Hip Femoral
Head-Bore and Cone Taper
Interface.
11-266........................... .............. ASTM F2665-09 (Reapproved 2014) Reaffirmation.
Standard Specification for
Total Ankle Replacement
Prosthesis.
11-224........................... .............. ASTM F2706-08 (Reapproved 2014) Reaffirmation.
Standard Test Methods for
Occipital-Cervical and
Occipital-Cervical-Thoracic
Spinal Implant Constructs in a
Vertebrectomy Model..
11-80............................ 11-290 ISO 8828 Second edition 2014-11- Withdrawn and replaced with
15 Implants for surgery-- newer version.
Guidance on Care and Handling
of Orthopaedic Implants.
11-248........................... 11-291 ISO 14242-1 Third edition 2014- Withdrawn and replaced with
10-15 Implants for surgery-- newer version.
Wear of total hip-joint
prostheses--Part 1: Loading and
displacement parameters for
wear testing machines and
corresponding environmental
conditions for test.
11-250........................... 11-292 ISO 14243-3 Second edition 2014- Withdrawn and replaced with
11-01 Implants for surgery-- newer version.
Wear of total knee prostheses--
Part 3: Loading and
displacement parameters for
wear--testing machines with
displacement control and
corresponding environmental
conditions for test.
----------------------------------------------------------------------------------------------------------------
N. Radiology
----------------------------------------------------------------------------------------------------------------
12-102........................... .............. ANSI/IESNA RP-27.2-2000 Reaffirmation.
(Reaffirmed 2011)
Photobiological Safety for Lamp
& Lamp Systems-Measurement
Techniques.
12-212........................... 12-289 IEC 62220-1-1 Edition 1.0 2015- Withdrawn and replaced with
03 Medical electrical newer version.
equipment--Characteristics of
digital x-ray imaging devices--
Part 1-1: Determination of the
detective quantum efficiency--
Detectors used in radiographic
imaging.
12-229........................... 12-290 IEC 61910-1 Edition 1.0 2014-09 Withdrawn and replaced with
Medical electrical equipment-- newer version.
Radiation dose documentation--
Part 1: Radiation dose
structured reports for
radiography and radioscopy.
12-278........................... 12-291 IEC 62127-2 Edition 1.1 2013-02 Withdrawn and replaced with
Ultrasonics Hydrophones--Part newer version.
2: Calibration for ultrasonic
fields up to 40 MHz.
----------------------------------------------------------------------------------------------------------------
O. Sterility
----------------------------------------------------------------------------------------------------------------
14-193........................... 14-457 ANSI/AAMI/ISO 11607-1:2006/ Withdrawn and replaced with
(R)2010 Packaging for newer version including
terminally sterilized medical Amendment.
devices--Part 1: Requirements
for materials, sterile barrier
systems and packaging
[Including: Amendment 1 (2014)].
14-194........................... 14-458 ANSI/AAMI/ISO 11607-2:2006/ Withdrawn and replaced with
(R)2010 Packaging for newer version including
terminally sterilized medical Amendment.
devices--Part 2: Validation
requirements for forming,
sealing and assembly
processes[Including: Amendment
1 (2014)].
14-195........................... 14-459 ANSI/AAMI/ISO 11140-1:2014 Withdrawn and replaced with
Sterilization of health care newer version.
products--Chemical indicators--
Part 1: General requirements.
14-287........................... .............. ANSI/AAMI/ISO 11737-2:2009/ Reaffirmation.
(R)2014 Sterilization of
medical devices--
Microbiological methods--Part
2: Tests of sterility performed
in the definition, validation
and maintenance of a
sterilization process.
[[Page 48876]]
14-297........................... 14-461 ANSI/AAMI/ISO 11137-1:2006/(R) Withdrawn and replaced with
2010 Sterilization Of Health newer version including
Care Products--Radiation--Part Amendment.
1: Requirements For
Development, Validation, And
Routine Control Of A
Sterilization Process For
Medical Devices [Including:
Amendment 1 (2013)].
14-300........................... 14-462 ASTM D4169--14 Standard Practice Withdrawn and replaced with
for Performance Testing of newer version.
Shipping Containers and Systems.
14-327........................... .............. ISO 11737-2 Second edition 2009- Extent of Recognition.
11-15 Sterilization of medical
devices--Microbiological
methods--Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a sterilization
process.
14-350........................... .............. ANSI/AAMI/ISO 13408-4:2005/ Reaffirmation.
(R)2014, Aseptic processing of
health care products--Part 4:
Clean-in-place technologies.
14-353........................... 14-460 ISO 11140-1 Third edition 2014- Withdrawn and replaced with
11-01 Sterilization of health newer version.
care products--Chemical
indicators--Part 1: General
requirements.
14-391........................... 14-463 ISO/ASTM 51608 Third edition Withdrawn and replaced with
2015-03-15 Practice for newer version.
dosimetry in an X-ray
(bremsstrahlung) facility for
radiation processing at
energies between 50 KeV and 7.5
MeV.
14-392........................... 14-464 ISO/ASTM 51649 Third edition Withdrawn and replaced with
2015-03-15 Practice for newer version.
dosimetry in an electron beam
facility for radiation
processing at energies between
300 keV and 25 MeV.
14-431........................... 14-465 ISO/ASTM 51707 Third edition Withdrawn and replaced with
2015-03-15 Guide for estimation newer version.
of measurement uncertainty in
dosimetry for radiation
processing.
14-440........................... 14-466 USP 38-NF33:2015 <61> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Microbial
Enumeration Tests.
14-441........................... 14-467 USP 38-NF33:2015 <71> Sterility Withdrawn and replaced with
Tests. newer version.
14-442........................... 14-468 USP 38-NF33:2015 <85> Bacterial Withdrawn and replaced with
Endotoxins Test. newer version.
14-443........................... 14-477 USP 38-NF33:2015 <151> Pyrogen Withdrawn and replaced with
Test (USP Rabbit Test). newer version.
14-444........................... 14-469 USP 38-NF33:2015 <161> Withdrawn and replaced with
Transfusion and Infusion newer version.
Assemblies and Similar Medical
Devices.
14-445........................... 14-470 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization--Self Contained.
14-446........................... 14-471 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Dry-Heat newer version.
Sterilization, Paper Carrier.
14-447........................... 14-472 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Ethylene Oxide newer version.
Sterilization, Paper Carrier.
14-448........................... 14-473 USP 38-NF33:2015 Biological Withdrawn and replaced with
Indicator for Steam newer version.
Sterilization, Paper Carrier.
14-449........................... 14-474 USP 38-NF33:2015 <62> Withdrawn and replaced with
Microbiological Examination of newer version.
Nonsterile Products: Tests for
Specified Microorganisms.
14-450........................... 14-475 USP 38-NF33:2015 <55> Biological Withdrawn and replaced with
Indicators--Resistance newer version.
Performance Tests.
14-451........................... 14-476 USP 38-NF33:2015 <1035> Withdrawn and replaced with
Biological Indicators for newer version.
Sterilization.
----------------------------------------------------------------------------------------------------------------
\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: 040.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
1-104.................... Medical electrical ISO 80601-2-13
equipment--Part 2-13: First Edition 2011-
Particular Requirements 08-01 and
for basic safety and Amendment 1 2015.
essential performance
of an anaesthetic
workstation [Including:
Amendment 1 (2015)].
1-105.................... Medical electrical ISO 80601-2-72
equipment--Part 2-72: First Edition 2015-
Particular requirements 04-11.
for basic safety and
essential performance
of home healthcare
environment ventilators
for ventilator-
dependent patients.
------------------------------------------------------------------------
[[Page 48877]]
B. Biocompatibility
------------------------------------------------------------------------
2-221.................... Biological Evaluation of ANSI/AAMI/ISO 10993-
Medical Devices: Part 2:2006 (R2014).
2--Animal Welfare
Requirements.
2-222.................... Biological Evaluation of ISO 10993-2 Second
Medical Devices: Part edition 2006-07-
2--Animal Welfare 15.
Requirements.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-135.................... Cardiovascular implants ISO/TS 12417-1
and extracorporeal First edition 2011-
systems--Vascular 06-01.
device-drug combination
products.
3-136.................... Cardiovascular implants ANSI/AAMI/ISO
and extracorporeal TIR12417:2011.
systems--Vascular
device-drug combination
products.
3-137.................... Standard Guide for ASTM F3036-13.
Testing Absorbable
Stents.
3-138.................... Standard Guide for in ASTM F2942-13.
vitro Axial, Bending,
and Torsional
Durability Testing of
Vascular Stents.
3-139.................... Active implantable ISO 14117 First
medical devices-- edition 2012-07-
Electromagnetic 15.
compatibility--EMC test
protocols for
implantable cardiac
pacemakers, implantable
cardioverter
defibrillators and
cardiac
resynchronization
devices.
------------------------------------------------------------------------
D. General I (Quality Systems/Risk Management)
------------------------------------------------------------------------
5-95..................... Medical devices--Part 1: IEC 62366-1 Edition
Application of 1.0 2015-02.
usability engineering
to medical devices.
5-96..................... Medical devices--Part 1: ANSI/AAMI/IEC 62366-
Application of 1:2015.
usability engineering
to medical devices.
5-97..................... Small-bore connectors ISO 80369-20 First
for liquids and gases edition 2015-05-
in healthcare 15.
applications--Part 20:
Common test methods.
------------------------------------------------------------------------
E. General II (ES/EMC)
------------------------------------------------------------------------
19-14.................... Medical electrical IEC 60601-1-11
equipment--Part 1-11: Edition 2.0 2015-
General requirements 01.
for basic safety and
essential performance--
Collateral Standard:
Requirements for
medical electrical
equipment and medical
electrical systems used
in the home healthcare
environment.
19-15.................... Medical electrical IEC 60601-1-12
equipment--Part 1-12: Edition 1.0 2014-
General requirements 06.
for basic safety and
essential performance--
Collateral Standard:
Requirements for
medical electrical
equipment and medical
electrical systems
intended for use in the
emergency medical
services environment.
------------------------------------------------------------------------
F. GH/GPS
------------------------------------------------------------------------
6-352.................... Standard Specification ASTM F703-07.
for Implantable Breast
Prostheses.
6-353.................... Standard Specification ASTM F2051-00
for Implantable Saline (Reapproved 2014).
Filled Breast
Prosthesis.
6-354.................... Standard Specification ASTM D7866-14.
for Radiation
Attenuating Protective
Gloves.
------------------------------------------------------------------------
G. IVD
------------------------------------------------------------------------
7-257.................... Principles and CLSI M56-A.
procedures for
Detection of Anaerobes
in Clinical Specimens;
Approved Guideline.
7-258.................... Performance Standards CLSI M02-A12.
for Antimicrobial Disk
Susceptibility Tests;
Approved Standards-
Twelfth Edition.
------------------------------------------------------------------------
H. Materials
------------------------------------------------------------------------
8-388.................... Implants for surgery-- ISO 6474-2 First
Ceramic materials--Part edition 2012-04-
2: Composite materials 15.
based on a high-purity
alumina matrix with
zirconia reinforcement.
8-389.................... Implants for surgery-- ISO 15309 First
Differential scanning edition 2013-12-
calorimetry of poly 01.
ether ether ketone
(PEEK) polymers and
compounds for use in
implantable medical
devices.
8-390.................... Standard Specification ASTM F1925-09.
for Semi-Crystalline
Poly(lactide) Polymer
and Copolymer Resins
for Surgical Implants.
8-391.................... Standard Specification ASTM F2313-10.
for Poly(glycolide) and
Poly(glycolide-co-
lactide) Resins for
Surgical Implants with
Mole Fractions Greater
Than or Equal To 70%
Glycolide.
------------------------------------------------------------------------
I. Nanotechnology
------------------------------------------------------------------------
18-4..................... Technical Specification-- ISO/TS 80004-6
Nanotechnologies--Vocab First edition 2013-
ulary--Part 6: Nano- 11-01.
object characterization.
------------------------------------------------------------------------
J. Neurology
------------------------------------------------------------------------
17-14.................... Transcutaneous ANSI/AAMI NS4:2013.
electrical nerve
stimulators.
------------------------------------------------------------------------
[[Page 48878]]
K. OB-GYN-GU/Gastroenterology
------------------------------------------------------------------------
9-103.................... Water treatment ANSI/AAMI
equipment for 26722:2014.
hemodialysis and
related therapies.
------------------------------------------------------------------------
L. Ophthalmic
------------------------------------------------------------------------
10-99.................... Anionic and non-ionic ISO 4311 First
surface active agents-- edition 1979-06-
Determination of 01.
critical micellization
concentration--Method
by measuring surface
tension with a plate,
stirrup, or ring,.
------------------------------------------------------------------------
M. Orthopedic
------------------------------------------------------------------------
11-293................... Standard Test Method for ASTM F2582-14.
Impingement of
Acetabular Prostheses.
11-294................... Standard Specification ASTM F1357-14.
for Articulating Total
Wrist Implants.
11-295................... Standard Practice for ASTM F2580-13.
Evaluation of Modular
Connection of
Proximally Fixed
Femoral Hip Prosthesis.
------------------------------------------------------------------------
N. Physical Medicine
------------------------------------------------------------------------
16-194................... Wheelchairs Part ISO 7176-25 First
25:Batteries and edition 2013-07-
chargers for powered 15.
wheelchairs.
------------------------------------------------------------------------
O. Radiology
------------------------------------------------------------------------
12-292................... IEEE Recommended IEEE Std 3333.2.1-
Practice for Three- 2015.
Dimensional (3D)
Medical Modeling.
------------------------------------------------------------------------
P. Software/Informatics
------------------------------------------------------------------------
13-73.................... Systematized IHTSDO SNOME-CT RF2
Nomenclature of Release 2015.
Medicine--Clinical
Terms.
13-74.................... Health informatics-- IEEE Std 11073-
Personal health device 10424-2014.
communication, Part
10424: Device
Specialization--Sleep
Apnoea Breathing
Therapy Equipment
(SABTE).
13-75.................... Health informatics-- ISO/IEEE 11073-
Point-of-care medical 10102 First
device communication-- edition 2014-03-
Part 10102: 01.
Nomenclature--Annotated
ECG.
13-76.................... Health informatics-- ISO 11073-91064
Standard communication First edition 2009-
protocol--Part 91064: 05-01.
Computer-assisted
electrocardiography.
13-77.................... Information technology-- ISO/IEC 29147 First
Security techniques-- edition 2014-02-
Vulnerability 15.
disclosure.
13-78.................... Information technology-- ISO/IEC 30111 First
Security techniques-- edition 2013-11-
Vulnerability handling 01.
processes.
------------------------------------------------------------------------
Q. Sterility
------------------------------------------------------------------------
14-478................... Flexible and semi-rigid ANSI/AAMI
endoscope processing in ST91:2015.
health care facilities.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
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 https://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, https://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
[[Page 48879]]
Recognized Standards, Recognition List Number: 040'' will be available
at https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.
VII. Submission of Comments and Effective Date
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. 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: 040. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19991 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P
