Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 052, 57034-57041 [2019-23198]
Download as PDF
<![CDATA[
57034
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity/21 CFR or FD&C Act Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Periodic reports (814.84(b)) .................................................
Breakthrough Devices Program (515(B) of the FD&C Act)
Agreement meeting (520(g)(7) of the FD&C Act) ...............
Determination Meeting (513(a)(3)(D) of the FD&C Act) ......
Panel meeting (515(c)(3) of the FD&C Act) ........................
Day 100 meeting (515(d)(3) of the FD&C Act) ...................
764
11
1
1
1
14
1
1
1
1
1
1
764
11
1
1
1
14
10
10
50
50
30
10
7,640
110
50
50
30
140
Total ..............................................................................
........................
........................
........................
........................
384,936
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total Hours
Maintenance of records (814.82(a)(5) and (6)) ...................
446
1
446
17
7,582
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We made the following changes to the
information collection:
• Added the burden estimate for
‘‘Information on clinical investigations
conducted outside the United States
(814.20(b)(6)(ii)(C)),’’ which is
associated with the ‘‘Human Subject
Protection; Acceptance of Data from
Clinical Investigations for Medical
Devices’’ final rule as described
previously in this document.
• Revised the burden description and
table to reflect that the Expedited
Access Pathway and Priority Review
have been superseded by the
Breakthrough Devices Program.
• Updated our burden estimate with
FYs 2016 to 2018 data.
These adjustments resulted in an
overall increase of 34,782 hours to the
estimated burden.
Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23204 Filed 10–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
052
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:34 Oct 23, 2019
Jkt 250001
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: 052’’
(Recognition List Number: 052), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
October 24, 2019.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
SUMMARY:
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 052.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday. FDA will consider any
comments received in determining
whether to amend the current listing of
E:\FR\FM\24OCN1.SGM
24OCN1
57035
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
modifications to the list of recognized
standards, Recognition List Number:
052.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
An electronic copy of Recognition List
Number: 052 is available on the internet
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
IV for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 052
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: 052’’ to Scott
Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5514, Silver Spring,
MD 20993, 301–796–6287. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8144.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring,
MD 20993, 301–796–6287,
CDRHStandardsStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
514 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions or other requirements.
In the Federal Register of September
14, 2018 (83 FR 46738), FDA announced
the availability of a guidance entitled
‘‘Appropriate Use of Voluntary
Consensus Standards in Premarket
Submissions for Medical Devices.’’ The
guidance describes how FDA has
implemented its standards recognition
program and is available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
appropriate-use-voluntary-consensusstandards-premarket-submissionsmedical-devices. Modifications to the
initial list of recognized standards, as
published in the Federal Register, can
be accessed at https://www.fda.gov/
medical-devices/standards-andconformity-assessment-program/federalregister-documents.
These notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language (HTML) and portable
document format (PDF) versions of the
list of FDA Recognized Consensus
Standards. Additional information on
the Agency’s Standards and Conformity
Assessment Program is available at
https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/standards-andconformity-assessment-program.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 052
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
is recognizing for use in premarket
submissions and other requirements for
devices. FDA is incorporating these
modifications to the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA is
using the term ‘‘Recognition List
Number: 052’’ to identify the current
modifications.
In Table 1, FDA describes the
following modifications: (1) The
withdrawal of standards and their
replacement by others, if applicable; (2)
the correction of errors made by FDA in
listing previously recognized standards;
and (3) the changes to the
supplementary information sheets of
recognized standards that describe
revisions to the applicability of the
standards.
In section III, FDA lists modifications
the Agency is making that involve new
entries and consensus standards added
as modifications to the list of recognized
standards under Recognition List
Number: 052.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
khammond on DSKJM1Z7X2PROD with NOTICES
Old
Recognition
No.
Replacement
Recognition
No.
Title of standard 1
Change
A. Anesthesiology
1–116 ..............
........................
1–122 ..............
........................
1–125 ..............
........................
VerDate Sep<11>2014
17:34 Oct 23, 2019
ISO 5360 Fourth edition 2016–02–15 Anaesthetic vaporizers—Agent
specific filling systems.
ISO 5364 Fifth edition 2016–09–01 Anaesthetic and respiratory
equipment—Oropharyngeal airways.
ISO 8836 Fourth edition 2014–10–15 Suction catheters for use in the
respiratory tract.
Jkt 250001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\24OCN1.SGM
Extent of Recognition.
Extent of Recognition.
Extent of Recognition.
24OCN1
57036
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
Recognition
No.
Replacement
Recognition
No.
1–126 ..............
........................
1–131 ..............
1–142 .............
Title of standard 1
Change
ISO 11712 First edition 2009–05–15 Anaesthetic and respiratory
equipment—Supralaryngeal airways and connectors.
ISO 10079–1 Third Edition 2015–11–01 Medical suction equipment—
Part 1: Electrically powered suction equipment [Including AMENDMENT 1 (2018)].
Extent of Recognition.
Withdrawn and replaced with newer
version including amendment.
B. Biocompatibility
2–162 ..............
2–263 .............
2–206 ..............
2–264 .............
2–223 ..............
2–265 .............
2–257 ..............
2–266 .............
ASTM F1903–18 Standard Practice for Testing for Cellular Responses to Particles in vitro.
ASTM F2148–18 Standard Practice for Evaluation of Delayed Contact
Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
ASTM F2901–19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices.
ASTM F2382–18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT).
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
C. Cardiovascular
3–122 ..............
3–160 .............
3–123 ..............
........................
3–137 ..............
........................
ISO 81060–2 Third edition 2018–11 Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type.
IEC 80601–2–30 Edition 2.0 2018–03 Medical electrical equipment—
Part 2–30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers.
ASTM F3036–13 Standard Guide for Testing Absorbable Stents ........
Withdrawn and replaced with newer
version.
Extent of Recognition.
Extent of Recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4–182 ..............
4–258 .............
4–196 ..............
........................
ISO 10139–2 Third edition 2016–06–15 Dentistry—Soft lining materials for removable dentures—Part 2: Materials for long-term use.
ISO 6872 Third edition 2008–09–01 Dentistry—Ceramic materials .....
Withdrawn and replaced with newer
version.
Withdrawn. See #4–223.
E. General I (Quality Systems/Risk Management) (QS/RM)
5–109 ..............
5–123 .............
5–115 ..............
........................
ISO 80369–3 First edition 2016–07–01 Small-bore connectors for
uids and gases in healthcare applications —Part 3: Connectors
enteral applications [Including AMENDMENT 1 (2019)].
ISO 80369–7 First edition 2016–10–15 Small-bore connectors for
uids and gases in healthcare applications—Part 7: Connectors
intravascular or hypodermic applications.
liqfor
Withdrawn and replaced with newer
version including amendment.
liqfor
Transition removed.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
khammond on DSKJM1Z7X2PROD with NOTICES
G. General Hospital/General Plastic Surgery (GH/GPS)
6–11 ................
........................
ISO 594–1 First edition 1986–06–15 Conical fittings with a 6% (Luer)
taper for syringes, needles and certain other medical equipment—
Part 1: General requirements.
Transition removed. Recognition restored.
6–129 ..............
........................
Transition removed. Recognition restored.
6–403 ..............
6–421 .............
ISO 594–2 Second edition 1998–09–01 Conical fittings with a 6%
(Luer) taper for syringes, needles and certain other medical equipment—Part 2: Lock fittings.
ISO 80601–2–56 Second edition 2017–03 Medical electrical equipment—Part 2–56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature
measurement [Including AMENDMENT 1 (2018)].
Withdrawn and replaced with newer
version including amendment.
H. In Vitro Diagnostics (IVD)
7–215 ..............
7–287 .............
7–222 ..............
7–288 .............
VerDate Sep<11>2014
17:34 Oct 23, 2019
CLSI M44–S3 (2018) Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive
Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion
Susceptibility Testing of Yeasts; Third Informational Supplement.
CLSI M24 3rd Edition Susceptibility Testing of Mycobacteria,
Nocardia spp., and Other Aerobic Actinomycetes.
Jkt 250001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
E:\FR\FM\24OCN1.SGM
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
24OCN1
57037
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
Recognition
No.
Replacement
Recognition
No.
7–274 ..............
7–289 .............
Title of standard 1
Change
CLSI MM17 2nd Edition Validation and Verification of Multiplex Nucleic Acid Assays.
Withdrawn and replaced with newer
version.
I. Materials
8–132 ..............
8–491 .............
8–150 ..............
8–492 .............
8–188 ..............
8–493 .............
8–194 ..............
8–494 .............
8–213 ..............
8–495 .............
8–214 ..............
8–496 .............
8–215 ..............
8–497 .............
8–229 ..............
8–498 .............
8–331 ..............
8–499 .............
8–351 ..............
8–500 .............
8–352 ..............
8–501 .............
8–359 ..............
8–502 .............
8–360 ..............
8–503 .............
8–370 ..............
8–504 .............
8–388 ..............
8–505 .............
8–397 ..............
8–506 .............
8–402 ..............
8–507 .............
8–411 ..............
8–508 .............
ASTM F1088–18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation.
ISO 5832–9 Third edition 2019–02 Implants for surgery—Metallic materials—Part 9: Wrought high nitrogen stainless steel.
ISO 13779–2 Third edition 2018–12 Implants for surgery—
Hydroxyapatite—Part
2:
Thermally
sprayed
coatings
of
hydroxyapatite.
ISO 6474–1 Second edition 2019–03 Implants for surgery—Ceramic
materials—Part 1: Ceramic materials based on high purity alumina.
ISO 5834–3 Second edition 2019–02 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 3: Accelerated ageing
methods.
ISO 5834–4 Second edition 2019–02 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 4: Oxidation index measurement method.
ISO 5834–5 Second edition 2019–02 Implants for surgery—Ultrahigh-molecular-weight polyethylene—Part 5: Morphology assessment
method.
ASTM F75–18 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075).
ASTM F1580–18 Standard Specification for Titanium and Titanium-6
Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants.
ISO 5832–12 Third edition 2019–02 Implants for surgery—Metallic
materials—Part 12: Wrought cobalt-chromium-molybdenum alloy.
ISO 5834–1 Fourth edition 2019–02 Implants for surgery—Ultra-highmolecular-weight polyethylene—Part 1: Powder form.
ASTM F2038—18 Standard Guide for Silicone Elastomers, Gels, and
Foams Used in Medical Applications Part I—Formulations and
Uncured Materials.
ASTM F2042–18 Standard Guide for Silicone Elastomers, Gels, and
Foams Used in Medical Applications Part II—Crosslinking and Fabrication.
ASTM F561–19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids.
ISO 6474–2 Second edition 2019–03 Implants for surgery—Ceramic
materials—Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement.
ASTM F2516–18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials.
ASTM F688–19 Standard Specification for Wrought Cobalt-35Nickel20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical
Implants (UNS R30035).
ASTM F2579–18 Standard Specification for Amorphous Poly(lactide)
and Poly(lactide-co-glycolide) Resins for Surgical Implants.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
J. Nanotechnology
No new entries at this time.
K. Neurology
khammond on DSKJM1Z7X2PROD with NOTICES
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
10–89 ..............
VerDate Sep<11>2014
........................
17:34 Oct 23, 2019
ANSI Z80.7–2013 (R2018) American National Standard for Ophthalmic
Optics—Intraocular Lenses.
Jkt 250001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
E:\FR\FM\24OCN1.SGM
Extent of recognition.
24OCN1
57038
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
Recognition
No.
Replacement
Recognition
No.
Title of standard 1
Change
N. Orthopedic
11–250 ............
11–349 ...........
11–251 ............
11–350 ...........
11–273 ............
11–351 ...........
11–291 ............
11–352 ...........
ISO 14242–3 First edition 2009–03–15 Implants for surgery—Wear of
total hip-joint prostheses—Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)].
ASTM F2554–18 Standard Practice for Measurement of Positional
Accuracy of Computer Assisted Surgical Systems.
ISO 18192–1 Second edition 2011–03–01 Implants for surgery—
Wear of total intervertebral spinal disc prostheses—Part 1: Loading
and displacement parameters for wear testing and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)].
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 [Including AMENDMENT 1 (2018)].
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version including amendment.
O. Physical Medicine
No new entries at this time.
P. Radiology
12–225 ............
12–325 ...........
NEMA XR 25–2019
Computed Tomography Dose Check ...................
Withdrawn and replaced with newer
version.
12–265 ............
12–326 ...........
NEMA NU 2–2018 Performance Measurements of Positron Emission
Tomographs (PETS).
Withdrawn and replaced with newer
version.
Q. Software/Informatics
No new entries at this time.
R. Sterility
14–377 ............
14–527 ...........
ASTM F2638–18 Standard Test Method for Using Aerosol Filtration
for Measuring the Performance of Porous Packaging Materials as a
Surrogate Microbial Barrier.
Withdrawn and replaced with newer
version.
14–428 ............
14–528 ...........
Withdrawn and replaced with newer
version including amendment.
14–452 ............
14–529 ...........
14–454 ............
14–530 ...........
14–455 ............
14–531 ...........
ISO 11137–1 First edition 2006–04–15 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) and AMENDMENT 2 (2018)].
ISO 11135 Second edition 2014–07–15 Sterilization of health-care
products—Ethylene oxide—Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: AMENDMENT 1 (2018)].
ISO 11607–1 Second edition 2019–02 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile
barrier systems and packaging systems.
ISO 11607–2 Second edition 2019–02 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming,
sealing and assembly processes.
Withdrawn and replaced with newer
version including amendment.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
khammond on DSKJM1Z7X2PROD with NOTICES
S. Tissue Engineering
15–27 ..............
15–57 .............
F2315–18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels.
Withdrawn and replaced with newer
version.
15–28 ..............
15–58 .............
F2103–18 Standard Guide for Characterization and Testing of
Chitosan Salts as Starting Materials Intended for Use in Biomedical
and Tissue-Engineered Medical Product Applications.
Withdrawn and replaced with newer
version.
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
VerDate Sep<11>2014
17:34 Oct 23, 2019
Jkt 250001
added as modifications to the list of
recognized standards under Recognition
List Number: 052. These entries are of
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
standards not previously recognized by
FDA.
E:\FR\FM\24OCN1.SGM
24OCN1
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
57039
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. Anesthesiology
1–143 ..............
1–144 ..............
Medical electrical equipment—Part 2–79: Particular requirements for basic safety
and essential performance of ventilatory support equipment for ventilatory impairment.
Medical electrical equipment—Part 2–80: Particular requirements for basic safety
and essential performance of ventilatory support equipment for ventilatory insufficiency.
ISO 80601–2–79 First edition 2018–07.
ISO 80601–2–80 First edition 2018–07.
B. Biocompatibility
2–267 ..............
2–268 ..............
Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for
Hemocompatibility Assessment of Cardiovascular Materials.
Biological evaluation of medical devices—Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.
ASTM F2888—19.
ISO/TS 21726 First edition 2019–02.
C. Cardiovascular
.........................
No new entries at this time.
D. Dental/Ear, Nose, and Throat (ENT)
4–259 ..............
Dentistry—Implants—Dynamic loading test for endosseous dental implants ............
ISO 14801 Third edition
2016–11–01.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–35 ..............
Standard for Standby Batteries ...................................................................................
UL 1989 Edition 5, 2013–10–02, ANSI
November 2018.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–422 ..............
6–423 ..............
Medical device safety assurance case guidance .......................................................
CONSOLIDATED VERSION Medical electrical equipment—Part 2–6: Particular requirements for the basic safety and essential performance of microwave therapy
equipment.
AAMI TIR38:2019.
IEC 60601–2–6 Edition 2.1 2016–04.
H. In Vitro Diagnostics (IVD)
7–290 ..............
7–291 ..............
7–292 ..............
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking.
How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays;
Approved Guideline.
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp.,
and other Aerobic Actinomycetes.
CLSI EP34 1st Edition.
CLSI EP27–A Vol. 32 No. 12, Replaces
EP27–P Vol. 29 No. 16.
CLSI M62 1st Edition.
I. Materials
8–509 ..............
8–510 ..............
8–511 ..............
8–512 ..............
khammond on DSKJM1Z7X2PROD with NOTICES
8–513 ..............
8–514 ..............
8–515 ..............
8–516 ..............
8–517 ..............
8–518 ..............
VerDate Sep<11>2014
Standard Specification for Polysulfone Resin for Medical Applications .....................
Standard Specification for Polycarbonate Resin for Medical Applications .................
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer
Resins for Surgical Implants.
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
Implants for surgery—Metallic materials—Classification of microstructures for
alpha+beta titanium alloy bars.
Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded
forms.
Implants for surgery—Hydroxyapatite—Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity.
Implants for surgery—Hydroxyapatite—Part 4: Determination of coating adhesion
strength.
Non-active surgical implants—Implant coating—Part 1: General requirements ........
Standard Test Method for Ion Release Evaluation of Medical Implants ....................
17:34 Oct 23, 2019
Jkt 250001
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
ASTM F702—18.
ASTM F997—18.
ASTM F1925—17.
ASTM F2026—17.
ISO 20160 First edition 2006–05–01.
ISO 5834–2 Fifth edition 2019–02.
ISO 13779–3 Second edition 2018–12.
ISO 13779–4 Second edition 2018–12.
ISO 17327–1 First edition 2018–02.
ASTM F3306—19.
E:\FR\FM\24OCN1.SGM
24OCN1
57040
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
J. Nanotechnology
18–13 ..............
18–14 ..............
Nanotechnologies—Electron spin resonance (ESR) as a method for measuring reactive oxygen species (ROS) generated by metal oxide nanomaterials.
Nanotechnologies—Methodology for the classification and categorization of nanomaterials.
ISO/TS 18827 First edition 2017–06.
ISO/TR 11360 First edition 2010–07–15.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
10–116 ............
10–117 ............
10–118 ............
American National Standard for Ophthalmics—Extended Depth of Focus Intraocular Lenses.
American National Standard for Ophthalmics—Slit-Lamp Microscopes ....................
American National Standard for Ophthalmics—Light Hazard from Operation Microscopes Used in Ocular Surgery.
ANSI Z80.35–2018.
ANSI Z80.37–2017.
ANSI Z80.38–2017.
N. Orthopedic
11–353 ............
11–354 ............
11–355 ............
11–356 ............
11–357 ............
11–358 ............
11–359 ............
Implants for surgery—Wear of total intervertebral spinal disc prostheses —Part 3:
Impingement-wear testing and corresponding environmental conditions for test of
lumbar prostheses under adverse kinematic conditions.
Standard Guide for Impingement Testing of Total Disc Prostheses ..........................
Implants for surgery—Metal intramedullary nailing systems—Part 1: Intramedullary
nails.
Implants for surgery—Metal intramedullary nailing systems—Part 2: Locking components.
Implants for surgery—Metal intramedullary nailing systems—Part 3: Connection
devices and reamer diameter instruments.
Implants for surgery—Wear of total hip-joint prostheses—Part 4: Testing hip prostheses under variations in component positioning which results in direct edge
loading.
Implants for surgery—Partial and total hip-joint prostheses—Part 10: Determination
of resistance to static load of modular femoral heads.
ISO 18192–3 First edition 2017–06.
ASTM F3295—18.
ISO 15142–1 First edition 2003–08–01.
ISO 15142–2 First edition 2003–08–01.
ISO 15142–3 First edition 2003–08–01.
ISO 14242–4 First edition 2018–05.
ISO 7206–10 Second edition 2018–08.
O. Physical Medicine
16–206 ............
Wheelchairs—Part 30: Wheelchairs for changing occupant posture—Test methods
and requirements.
ISO 7176–30 First edition 2018–12.
P. Radiology
No new entries at this time.
Q. Software/Informatics
13–108 ............
13–109 ............
Health informatics—Point-of-care medical device communication—Part 20701:
Service-Oriented Medical Device Exchange Architecture and Protocol Binding.
(American National Standard) Standard for Safety for Medical Device Interoperability.
IEEE Std 11073–20701–2018.
ANSI/AAMI/UL 2800–1: 2019.
R. Sterility
khammond on DSKJM1Z7X2PROD with NOTICES
14–532 ............
14–533 ............
Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass
Extraction Method.
Guidance on aspects of a risk-based approach to assuring sterility of terminally
sterilized, single-use health care product that is unable to withstand processing
to achieve maximally a sterility assurance level of 10¥6.
ASTM F3287—17e1.
ISO/TS 19930 First edition 2017–12.
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.
VerDate Sep<11>2014
18:38 Oct 23, 2019
Jkt 250001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
E:\FR\FM\24OCN1.SGM
24OCN1
Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has
recognized by notice published in the
Federal Register or that FDA has
decided to recognize but for which
recognition is pending (because a
periodic notice has not yet appeared in
the Federal Register). FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
following information available at
https://www.fda.gov/medical-devices/
standards-and-conformity-assessmentprogram/recognition-standard.
Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23198 Filed 10–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Sep<11>2014
17:34 Oct 23, 2019
Jkt 250001
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Microbial
(non-HIV) Diagnostics and Detection of
Infectious Agents, Food and Waterborne
Pathogens, and Methods in Microbial
Sterilization, Disinfection and
Bioremediation.
Date: November 14–15, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Gagan Pandya, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, RM 3200, MSC 7808,
Bethesda, MD 20892, 301–435–1167,
pandyaga@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cardiovascular Sciences.
Date: November 14–15, 2019.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites DC Convention
Center, 900 10th Street NW, Washington, DC
20001.
Contact Person: Margaret Chandler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4126,
MSC 7814, Bethesda, MD 20892, (301) 435–
1743, margaret.chandler@nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group;
Population and Public Health Approaches to
HIV/AIDS Study Section.
Date: November 14–15, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Old Town, 625 First
Street, Alexandria, VA 22315.
Contact Person: Jose H. Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5222,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Hematology.
Date: November 14–15, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bukhtiar H. Shah, DVM,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4120,
MSC 7802, Bethesda, MD 20892, 301–806–
7314, shahb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Radiation
Therapy and Biology.
Date: November 14–15, 2019.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
57041
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bo Hong, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD
20892, 301–996–6208, hongb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Accelerating the Pace of Drug Abuse
Research Using Existing Data.
Date: November 14, 2019.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kate Fothergill, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3142,
Bethesda, MD 20892, 301–435–2309,
fothergillke@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Nephrology.
Date: November 14, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Jianxin Hu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2156,
Bethesda, MD 20892, 301–827–4417,
jianxinh@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 18, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–23150 Filed 10–23–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57034-57041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23198]
-----------------------------------------------------------------------
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: 052
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 052'' (Recognition List Number: 052), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable October 24, 2019.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 052.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday. FDA will
consider any comments received in determining whether to amend the
current listing of
[[Page 57035]]
modifications to the list of recognized standards, Recognition List
Number: 052.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
An electronic copy of Recognition List Number: 052 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA recognized consensus standards, including Recognition List Number:
052 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: 052'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg.
66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions of
the list of FDA Recognized Consensus Standards. Additional information
on the Agency's Standards and Conformity Assessment Program is
available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 052
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 052'' to identify the current
modifications.
In Table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 052.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Old Recognition No. Replacement Recognition No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-116...................... ........................... ISO 5360 Fourth edition 2016- Extent of Recognition.
02-15 Anaesthetic
vaporizers--Agent specific
filling systems.
1-122...................... ........................... ISO 5364 Fifth edition 2016- Extent of Recognition.
09-01 Anaesthetic and
respiratory equipment--
Oropharyngeal airways.
1-125...................... ........................... ISO 8836 Fourth edition 2014- Extent of Recognition.
10-15 Suction catheters for
use in the respiratory tract.
[[Page 57036]]
1-126...................... ........................... ISO 11712 First edition 2009- Extent of Recognition.
05-15 Anaesthetic and
respiratory equipment--
Supralaryngeal airways and
connectors.
1-131...................... 1-142...................... ISO 10079-1 Third Edition Withdrawn and replaced
2015-11-01 Medical suction with newer version
equipment--Part 1: including amendment.
Electrically powered suction
equipment [Including
AMENDMENT 1 (2018)].
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-162...................... 2-263...................... ASTM F1903-18 Standard Withdrawn and replaced
Practice for Testing for with newer version.
Cellular Responses to
Particles in vitro.
2-206...................... 2-264...................... ASTM F2148-18 Standard Withdrawn and replaced
Practice for Evaluation of with newer version.
Delayed Contact
Hypersensitivity Using the
Murine Local Lymph Node
Assay (LLNA).
2-223...................... 2-265...................... ASTM F2901-19 Standard Guide Withdrawn and replaced
for Selecting Tests to with newer version.
Evaluate Potential
Neurotoxicity of Medical
Devices.
2-257...................... 2-266...................... ASTM F2382-18 Standard Test Withdrawn and replaced
Method for Assessment of with newer version.
Circulating Blood-Contacting
Medical Device Materials on
Partial Thromboplastin Time
(PTT).
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-122...................... 3-160...................... ISO 81060-2 Third edition Withdrawn and replaced
2018-11 Non-invasive with newer version.
sphygmomanometers--Part 2:
Clinical investigation of
intermittent automated
measurement type.
3-123...................... ........................... IEC 80601-2-30 Edition 2.0 Extent of Recognition.
2018-03 Medical electrical
equipment--Part 2-30:
Particular requirements for
the basic safety and
essential performance of
automated non-invasive
sphygmomanometers.
3-137...................... ........................... ASTM F3036-13 Standard Guide Extent of Recognition.
for Testing Absorbable
Stents.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-182...................... 4-258...................... ISO 10139-2 Third edition Withdrawn and replaced
2016-06-15 Dentistry--Soft with newer version.
lining materials for
removable dentures--Part 2:
Materials for long-term use.
4-196...................... ........................... ISO 6872 Third edition 2008- Withdrawn. See #4-223.
09-01 Dentistry--Ceramic
materials.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-109...................... 5-123...................... ISO 80369-3 First edition Withdrawn and replaced
2016-07-01 Small-bore with newer version
connectors for liquids and including amendment.
gases in healthcare
applications --Part 3:
Connectors for enteral
applications [Including
AMENDMENT 1 (2019)].
5-115...................... ........................... ISO 80369-7 First edition Transition removed.
2016-10-15 Small-bore
connectors for liquids and
gases in healthcare
applications--Part 7:
Connectors for intravascular
or hypodermic applications.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-11....................... ........................... ISO 594-1 First edition 1986- Transition removed.
06-15 Conical fittings with Recognition restored.
a 6% (Luer) taper for
syringes, needles and
certain other medical
equipment--Part 1: General
requirements.
----------------------------------------------------------------------------------------------------------------
6-129...................... ........................... ISO 594-2 Second edition 1998- Transition removed.
09-01 Conical fittings with Recognition restored.
a 6% (Luer) taper for
syringes, needles and
certain other medical
equipment--Part 2: Lock
fittings.
6-403...................... 6-421...................... ISO 80601-2-56 Second edition Withdrawn and replaced
2017-03 Medical electrical with newer version
equipment--Part 2-56: including amendment.
Particular requirements for
basic safety and essential
performance of clinical
thermometers for body
temperature measurement
[Including AMENDMENT 1
(2018)].
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-215...................... 7-287...................... CLSI M44-S3 (2018) Zone Withdrawn and replaced
Diameter Interpretive with newer version.
Standards, Corresponding
Minimal Inhibitory
Concentration (MIC)
Interpretive Breakpoints,
and Quality Control Limits
for Antifungal Disk
Diffusion Susceptibility
Testing of Yeasts; Third
Informational Supplement.
7-222...................... 7-288...................... CLSI M24 3rd Edition Withdrawn and replaced
Susceptibility Testing of with newer version.
Mycobacteria, Nocardia spp.,
and Other Aerobic
Actinomycetes.
[[Page 57037]]
7-274...................... 7-289...................... CLSI MM17 2nd Edition Withdrawn and replaced
Validation and Verification with newer version.
of Multiplex Nucleic Acid
Assays.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-132...................... 8-491...................... ASTM F1088-18 Standard Withdrawn and replaced
Specification for Beta- with newer version.
Tricalcium Phosphate for
Surgical Implantation.
8-150...................... 8-492...................... ISO 5832-9 Third edition 2019- Withdrawn and replaced
02 Implants for surgery-- with newer version.
Metallic materials--Part 9:
Wrought high nitrogen
stainless steel.
8-188...................... 8-493...................... ISO 13779-2 Third edition Withdrawn and replaced
2018-12 Implants for with newer version.
surgery--Hydroxyapatite--Par
t 2: Thermally sprayed
coatings of hydroxyapatite.
8-194...................... 8-494...................... ISO 6474-1 Second edition Withdrawn and replaced
2019-03 Implants for with newer version.
surgery--Ceramic materials--
Part 1: Ceramic materials
based on high purity alumina.
8-213...................... 8-495...................... ISO 5834-3 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 3:
Accelerated ageing methods.
8-214...................... 8-496...................... ISO 5834-4 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 4:
Oxidation index measurement
method.
8-215...................... 8-497...................... ISO 5834-5 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 5:
Morphology assessment method.
8-229...................... 8-498...................... ASTM F75-18 Standard Withdrawn and replaced
Specification for Cobalt-28 with newer version.
Chromium-6 Molybdenum Alloy
Castings and Casting Alloy
for Surgical Implants (UNS
R30075).
8-331...................... 8-499...................... ASTM F1580-18 Standard Withdrawn and replaced
Specification for Titanium with newer version.
and Titanium-6 Aluminum-4
Vanadium Alloy Powders for
Coatings of Surgical
Implants.
8-351...................... 8-500...................... ISO 5832-12 Third edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Metallic materials--
Part 12: Wrought cobalt-
chromium-molybdenum alloy.
8-352...................... 8-501...................... ISO 5834-1 Fourth edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 1: Powder
form.
8-359...................... 8-502...................... ASTM F2038--18 Standard Guide Withdrawn and replaced
for Silicone Elastomers, with newer version.
Gels, and Foams Used in
Medical Applications Part I--
Formulations and Uncured
Materials.
8-360...................... 8-503...................... ASTM F2042-18 Standard Guide Withdrawn and replaced
for Silicone Elastomers, with newer version.
Gels, and Foams Used in
Medical Applications Part
II--Crosslinking and
Fabrication.
8-370...................... 8-504...................... ASTM F561-19 Standard Withdrawn and replaced
Practice for Retrieval and with newer version.
Analysis of Medical Devices,
and Associated Tissues and
Fluids.
8-388...................... 8-505...................... ISO 6474-2 Second edition Withdrawn and replaced
2019-03 Implants for with newer version.
surgery--Ceramic materials--
Part 2: Composite materials
based on a high-purity
alumina matrix with zirconia
reinforcement.
8-397...................... 8-506...................... ASTM F2516-18 Standard Test Withdrawn and replaced
Method for Tension Testing with newer version.
of Nickel-Titanium
Superelastic Materials.
8-402...................... 8-507...................... ASTM F688-19 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-35Nickel-20Chromium-
10Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035).
8-411...................... 8-508...................... ASTM F2579-18 Standard Withdrawn and replaced
Specification for Amorphous with newer version.
Poly(lactide) and
Poly(lactide-co-glycolide)
Resins for Surgical Implants.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-89...................... ........................... ANSI Z80.7-2013 (R2018) Extent of recognition.
American National Standard
for Ophthalmic Optics--
Intraocular Lenses.
----------------------------------------------------------------------------------------------------------------
[[Page 57038]]
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-250..................... 11-349..................... ISO 14242-3 First edition Withdrawn and replaced
2009-03-15 Implants for with newer version.
surgery--Wear of total hip-
joint prostheses--Part 3:
Loading and displacement
parameters for orbital
bearing type wear testing
machines and corresponding
environmental conditions for
test [Including AMENDMENT 1
(2019)].
11-251..................... 11-350..................... ASTM F2554-18 Standard Withdrawn and replaced
Practice for Measurement of with newer version.
Positional Accuracy of
Computer Assisted Surgical
Systems.
11-273..................... 11-351..................... ISO 18192-1 Second edition Withdrawn and replaced
2011-03-01 Implants for with newer version.
surgery--Wear of total
intervertebral spinal disc
prostheses--Part 1: Loading
and displacement parameters
for wear testing and
corresponding environmental
conditions for test
[Including AMENDMENT 1
(2018)].
11-291..................... 11-352..................... ISO 14242-1 Third edition Withdrawn and replaced
2014-10-15 Implants for with newer version
surgery--Wear of total hip- including amendment.
joint prostheses --Part 1:
Loading and displacement
parameters for wear-testing
machines and corresponding
environmental conditions for
test [Including AMENDMENT 1
(2018)].
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-225..................... 12-325..................... NEMA XR 25-2019 Computed Withdrawn and replaced
Tomography Dose Check. with newer version.
----------------------------------------------------------------------------------------------------------------
12-265..................... 12-326..................... NEMA NU 2-2018 Performance Withdrawn and replaced
Measurements of Positron with newer version.
Emission Tomographs (PETS).
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-377..................... 14-527..................... ASTM F2638-18 Standard Test Withdrawn and replaced
Method for Using Aerosol with newer version.
Filtration for Measuring the
Performance of Porous
Packaging Materials as a
Surrogate Microbial Barrier.
----------------------------------------------------------------------------------------------------------------
14-428..................... 14-528..................... ISO 11137-1 First edition Withdrawn and replaced
2006-04-15 Sterilization of with newer version
health care products-- including amendment.
Radiation--Part 1:
Requirements for
development, validation and
routine control of a
sterilization process for
medical devices [Including
AMENDMENT 1 (2013) and
AMENDMENT 2 (2018)].
14-452..................... 14-529..................... ISO 11135 Second edition 2014- Withdrawn and replaced
07-15 Sterilization of with newer version
health-care products-- including amendment.
Ethylene oxide--Requirements
for the development,
validation and routine
control of a sterilization
process for medical devices
[Including: AMENDMENT 1
(2018)].
14-454..................... 14-530..................... ISO 11607-1 Second edition Withdrawn and replaced
2019-02 Packaging for with newer version.
terminally sterilized
medical devices--Part 1:
Requirements for materials,
sterile barrier systems and
packaging systems.
14-455..................... 14-531..................... ISO 11607-2 Second edition Withdrawn and replaced
2019-02 Packaging for with newer version.
terminally sterilized
medical devices--Part 2:
Validation requirements for
forming, sealing and
assembly processes.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-27...................... 15-57...................... F2315-18 Standard Guide for Withdrawn and replaced
Immobilization or with newer version.
Encapsulation of Living
Cells or Tissue in Alginate
Gels.
----------------------------------------------------------------------------------------------------------------
15-28...................... 15-58...................... F2103-18 Standard Guide for Withdrawn and replaced
Characterization and Testing with newer version.
of Chitosan Salts as
Starting Materials Intended
for Use in Biomedical and
Tissue-Engineered Medical
Product Applications.
----------------------------------------------------------------------------------------------------------------
\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: 052. These entries are of standards not
previously recognized by FDA.
[[Page 57039]]
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-143.................. Medical electrical ISO 80601-2-79 First
equipment--Part 2-79: edition 2018-07.
Particular requirements
for basic safety and
essential performance of
ventilatory support
equipment for
ventilatory impairment.
1-144.................. Medical electrical ISO 80601-2-80 First
equipment--Part 2-80: edition 2018-07.
Particular requirements
for basic safety and
essential performance of
ventilatory support
equipment for
ventilatory
insufficiency.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-267.................. Standard Practice for ASTM F2888--19.
Platelet Leukocyte
Count--An In-Vitro
Measure for
Hemocompatibility
Assessment of
Cardiovascular Materials.
2-268.................. Biological evaluation of ISO/TS 21726 First
medical devices-- edition 2019-02.
Application of the
threshold of
toxicological concern
(TTC) for assessing
biocompatibility of
medical device
constituents.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-259.................. Dentistry--Implants--Dyna ISO 14801 Third
mic loading test for edition
endosseous dental 2016-11-01.
implants.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-35.................. Standard for Standby UL 1989 Edition 5,
Batteries. 2013-10-02, ANSI
November 2018.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-422.................. Medical device safety AAMI TIR38:2019.
assurance case guidance.
6-423.................. CONSOLIDATED VERSION IEC 60601-2-6
Medical electrical Edition 2.1 2016-
equipment--Part 2-6: 04.
Particular requirements
for the basic safety and
essential performance of
microwave therapy
equipment.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-290.................. Establishing and CLSI EP34 1st
Verifying an Extended Edition.
Measuring Interval
Through Specimen
Dilution and Spiking.
7-291.................. How to Construct and CLSI EP27-A Vol. 32
Interpret an Error Grid No. 12, Replaces
for Quantitative EP27-P Vol. 29 No.
Diagnostic Assays; 16.
Approved Guideline.
7-292.................. Performance Standards for CLSI M62 1st
Susceptibility Testing Edition.
of Mycobacteria,
Nocardia spp., and other
Aerobic Actinomycetes.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-509.................. Standard Specification ASTM F702--18.
for Polysulfone Resin
for Medical Applications.
8-510.................. Standard Specification ASTM F997--18.
for Polycarbonate Resin
for Medical Applications.
8-511.................. Standard Specification ASTM F1925--17.
for Semi-Crystalline
Poly(lactide) Polymer
and Copolymer Resins for
Surgical Implants.
8-512.................. Standard Specification ASTM F2026--17.
for Polyetheretherketone
(PEEK) Polymers for
Surgical Implant
Applications.
8-513.................. Implants for surgery-- ISO 20160 First
Metallic materials-- edition 2006-05-01.
Classification of
microstructures for
alpha+beta titanium
alloy bars.
8-514.................. Implants for surgery-- ISO 5834-2 Fifth
Ultra-high-molecular- edition 2019-02.
weight polyethylene--
Part 2: Moulded forms.
8-515.................. Implants for surgery-- ISO 13779-3 Second
Hydroxyapatite--Part 3: edition 2018-12.
Chemical analysis and
characterization of
crystallinity ratio and
phase purity.
8-516.................. Implants for surgery-- ISO 13779-4 Second
Hydroxyapatite--Part 4: edition 2018-12.
Determination of coating
adhesion strength.
8-517.................. Non-active surgical ISO 17327-1 First
implants--Implant edition 2018-02.
coating--Part 1: General
requirements.
8-518.................. Standard Test Method for ASTM F3306--19.
Ion Release Evaluation
of Medical Implants.
------------------------------------------------------------------------
[[Page 57040]]
J. Nanotechnology
------------------------------------------------------------------------
18-13.................. Nanotechnologies--Electro ISO/TS 18827 First
n spin resonance (ESR) edition 2017-06.
as a method for
measuring reactive
oxygen species (ROS)
generated by metal oxide
nanomaterials.
18-14.................. Nanotechnologies--Methodo ISO/TR 11360 First
logy for the edition 2010-07-15.
classification and
categorization of
nanomaterials.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-116................. American National ANSI Z80.35-2018.
Standard for
Ophthalmics--Extended
Depth of Focus
Intraocular Lenses.
10-117................. American National ANSI Z80.37-2017.
Standard for
Ophthalmics--Slit-Lamp
Microscopes.
10-118................. American National ANSI Z80.38-2017.
Standard for
Ophthalmics--Light
Hazard from Operation
Microscopes Used in
Ocular Surgery.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-353................. Implants for surgery-- ISO 18192-3 First
Wear of total edition 2017-06.
intervertebral spinal
disc prostheses --Part
3: Impingement-wear
testing and
corresponding
environmental conditions
for test of lumbar
prostheses under adverse
kinematic conditions.
11-354................. Standard Guide for ASTM F3295--18.
Impingement Testing of
Total Disc Prostheses.
11-355................. Implants for surgery-- ISO 15142-1 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 1:
Intramedullary nails.
11-356................. Implants for surgery-- ISO 15142-2 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 2:
Locking components.
11-357................. Implants for surgery-- ISO 15142-3 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 3:
Connection devices and
reamer diameter
instruments.
11-358................. Implants for surgery-- ISO 14242-4 First
Wear of total hip-joint edition 2018-05.
prostheses--Part 4:
Testing hip prostheses
under variations in
component positioning
which results in direct
edge loading.
11-359................. Implants for surgery-- ISO 7206-10 Second
Partial and total hip- edition 2018-08.
joint prostheses--Part
10: Determination of
resistance to static
load of modular femoral
heads.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-206................. Wheelchairs--Part 30: ISO 7176-30 First
Wheelchairs for changing edition 2018-12.
occupant posture--Test
methods and requirements.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-108................. Health informatics--Point- IEEE Std 11073-20701-
of-care medical device 2018.
communication--Part
20701: Service-Oriented
Medical Device Exchange
Architecture and
Protocol Binding.
13-109................. (American National ANSI/AAMI/UL 2800-1:
Standard) Standard for 2019.
Safety for Medical
Device Interoperability.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-532................. Standard Test Method for ASTM F3287--17e1.
Nondestructive Detection
of Leaks in Packages by
Mass Extraction Method.
14-533................. Guidance on aspects of a ISO/TS 19930 First
risk-based approach to edition 2017-12.
assuring sterility of
terminally sterilized,
single-use health care
product that is unable
to withstand processing
to achieve maximally a
sterility assurance
level of 10-6.
------------------------------------------------------------------------
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 57041]]
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the following information available at
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/recognition-standard.
Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23198 Filed 10-23-19; 8:45 am]
BILLING CODE 4164-01-P
