The 510(k) Third Party Review Program; Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability, 14489-14491 [2020-05080]
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14489
Federal Register / Vol. 85, No. 49 / Thursday, March 12, 2020 / Notices
*** Program directors hold various roles and responsibilities and, therefore, have varied salaries. For the purpose of this estimate, the hourly
wages for the following managerial and post-secondary occupational codes were averaged: 11–3131,11–1021,11–9030,11–9033,11–9039, and
11–9199.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: March 6, 2020.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020–05027 Filed 3–11–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Refugee Support Services
(RSS) and RSS Set Aside Sub-Agency
List (New Collection)
Office of Refugee Resettlement;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) seeks
approval for a new information
collection requesting Refugee Support
Services (RSS) grantees and RSS Set
Aside grantees to provide the agency
name, city, state, phone number, and
funding amount for each contracted subgrantee.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
SUMMARY:
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: This new data collection
will request RSS grantees and RSS Set
Aside grantees to provide the agency
name, city, state, phone number, and
funding amount for each contracted subgrantee. Without having this
information regarding RSS sub-grantees,
the ACF Office of Refugee Resettlement
(ORR) does not know whether an agency
is, or is not, receiving ORR funds. This
makes it difficult to ensure
communications with, provide access to
targeted assistance for, and keep abreast
of the activities of all ORR-funded
refugee service providers.
Respondents: State governments and
replacement designees.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden hours
per response
Total
burden
hours
Annual
burden
hours
RSS and RSS Set Aside Sub-grantee List .........................
56
3
2
336
112
Estimated Total Annual Burden
Hours: 112.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
VerDate Sep<11>2014
16:31 Mar 11, 2020
Jkt 250001
to comments and suggestions submitted
within 60 days of this publication.
Authority: Refugee Act of 1980
[Immigration and Nationality Act, Title
IV, Chapter 2 Section 412 (e)] and 45
CFR 400.28.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–05035 Filed 3–11–20; 8:45 am]
BILLING CODE 4184–45–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2565]
The 510(k) Third Party Review
Program; Guidance for Industry, Food
and Drug Administration Staff, and
Third Party Review Organizations;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
Frm 00038
Fmt 4703
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E:\FR\FM\12MRN1.SGM
12MRN1
14490
Federal Register / Vol. 85, No. 49 / Thursday, March 12, 2020 / Notices
guidance entitled ‘‘510(k) Third Party
Review Program.’’ This guidance
provides a comprehensive look into
FDA’s current thinking regarding the
510(k) Third Party (3P510k) Review
Program authorized under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). Under the FDA Reauthorization
Act of 2017 (FDARA), FDA was directed
to issue guidance on the factors that will
be used in determining whether a class
I or class II device type, or subset of
such device types, is eligible for review
by an accredited person. The 3P510k
Review Program is intended to allow
review of devices by 3P510k Review
Organizations in order to provide
manufacturers of these devices an
alternative review process that allows
FDA to best utilize our resources on
higher risk devices.
DATES: The announcement of the
guidance is published in the Federal
Register on March 12, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
khammond on DSKJM1Z7X2PROD with NOTICES
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.
VerDate Sep<11>2014
16:31 Mar 11, 2020
Jkt 250001
• 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–
2016–D–2565 for ‘‘510(k) Third Party
Review Program.’’ 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.
• 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.govinfo.gov/content/pkg/FR-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
PO 00000
Frm 00039
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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 guidance
document entitled ‘‘510(k) Third Party
Review Program’’ to the Office of Policy,
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 self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Gregory Pishko, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3441, Silver Spring,
MD 20993–0002, 240–402–6635.
SUPPLEMENTARY INFORMATION:
I. Background
FDA’s implementation of section 523
of the FD&C Act (21 U.S.C. 360m)
establishes a process for recognition of
qualified third parties to conduct the
initial review of premarket notification
(510(k)) submissions for certain low-tomoderate risk devices eligible under the
3P510k Review Program. Under FDARA
(Pub. L. 115–52), the criteria used to
establish device eligibility in the 3P510k
Review Program changed and FDA was
directed to issue guidance on the factors
that will be used in determining
whether a class I or class II device type,
or subset of such device types, is
eligible for review by an accredited
person. The objectives of this guidance
are to describe the factors FDA will use
in determining device type eligibility for
review by 3P510k Review
Organizations; to outline FDA’s process
for the recognition, rerecognition,
suspension and withdrawal of
recognition for 3P510k Review
Organizations; and to ensure consistent
quality of work among 3P510k Review
Organizations through Medical Device
User Fee Amendments IV commitments
authorized under FDARA in order to
eliminate the need for routine,
substantive re-review by FDA. This
guidance also outlines FDA’s current
thinking on leveraging the International
Medical Device Regulators Forum’s
requirements for Regulatory Reviewers
under the Good Regulatory Review
Practices and the Medical Device Single
Audit Program.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of September 14,
2018 (83 FR 46742). FDA revised the
E:\FR\FM\12MRN1.SGM
12MRN1
Federal Register / Vol. 85, No. 49 / Thursday, March 12, 2020 / Notices
guidance as appropriate in response to
the comments. This guidance
supersedes ‘‘Implementation of Third
Party Programs Under the FDA
Modernization Act of 1997; Final
Guidance for Staff, Industry, and Third
Parties’’ issued on February 2, 2001, and
‘‘Guidance for Third Parties and FDA
Staff; Third Party Review of Premarket
Notifications’’ issued on September 28,
2004.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the 510(k) Third
Party Review Program. 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 statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the 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. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘510(k) Third Party Review Program’’
may send an email request to CDRH-
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
Topic
807 ................................................................................................................................
Medical Devices: Third-Party Review
under FDAMA.
Premarket notification ...............................
CDRH Appeals Process ...........................
Q-submissions ..........................................
Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05080 Filed 3–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0419]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 11, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0419 60D,
and project title for reference, to
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Guidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 17–028 to
identify the guidance you are
requesting.
21 CFR part or guidance
807, subpart E ..............................................................................................................
‘‘Center for Devices and Radiological Health (CDRH) Appeals Processes’’ ..............
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
VerDate Sep<11>2014
16:31 Mar 11, 2020
Jkt 250001
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Acquisition
Regulation Clause Patent Rights and
Rights and Data.
Type of Collection: Extension.
OMB No. 0990–0419.
Abstract: The Department of Health
and Human Services; Office of the
Assistant Secretary for Financial
Resources and Office of Grants and
Acquisition Policy and Accountability,
Division of Acquisition is requesting an
approval by OMB for an extension of a
previously approved information
collection request, Acquisition
Regulation Clause Patent rights and
Rights in Data. HHS found that
systematically, over a period of several
PO 00000
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14491
OMB control
No.
0910–0375
0910–0120
0910–0738
0910–0756
years, when Determination of
Exceptional Circumstances(DEC) were
executed, additional legal protection for
the patent and data rights of third
parties beyond those covered by FAR
27.306 were necessary A DEC is
executed consistent with the policy and
objectives of the Bayh-Dole Act, 35
U.S.C. 200, et seq., to ensure that subject
inventions made under contracts and
subcontracts (at all tiers) are used in a
manner to promote free competition and
enterprise without unduly encumbering
future research and discovery; to
encourage maximum participation of
small business firms in federally
supported research and development
efforts; to promote collaboration
between commercial concerns and
nonprofit organizations including
universities; to ensure that the
Government obtains sufficient rights in
federally supported inventions to meet
its needs; to protect the public against
nonuse or unreasonable use of
inventions; and in the case of fulfilling
the mission of the U.S. Department of
Health and Human Services, to
ultimately to benefit the public health.
Likely Respondents: Administrative,
technical, legal and management
personnel.
E:\FR\FM\12MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 49 (Thursday, March 12, 2020)]
[Notices]
[Pages 14489-14491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05080]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2565]
The 510(k) Third Party Review Program; Guidance for Industry,
Food and Drug Administration Staff, and Third Party Review
Organizations; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final
[[Page 14490]]
guidance entitled ``510(k) Third Party Review Program.'' This guidance
provides a comprehensive look into FDA's current thinking regarding the
510(k) Third Party (3P510k) Review Program authorized under the Federal
Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization
Act of 2017 (FDARA), FDA was directed to issue guidance on the factors
that will be used in determining whether a class I or class II device
type, or subset of such device types, is eligible for review by an
accredited person. The 3P510k Review Program is intended to allow
review of devices by 3P510k Review Organizations in order to provide
manufacturers of these devices an alternative review process that
allows FDA to best utilize our resources on higher risk devices.
DATES: The announcement of the guidance is published in the Federal
Register on March 12, 2020.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2016-D-2565 for ``510(k) Third Party Review Program.'' 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.
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.govinfo.gov/content/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 guidance document entitled
``510(k) Third Party Review Program'' to the Office of Policy, 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 self-addressed adhesive
label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Gregory Pishko, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3441, Silver Spring, MD 20993-0002, 240-402-6635.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's implementation of section 523 of the FD&C Act (21 U.S.C.
360m) establishes a process for recognition of qualified third parties
to conduct the initial review of premarket notification (510(k))
submissions for certain low-to-moderate risk devices eligible under the
3P510k Review Program. Under FDARA (Pub. L. 115-52), the criteria used
to establish device eligibility in the 3P510k Review Program changed
and FDA was directed to issue guidance on the factors that will be used
in determining whether a class I or class II device type, or subset of
such device types, is eligible for review by an accredited person. The
objectives of this guidance are to describe the factors FDA will use in
determining device type eligibility for review by 3P510k Review
Organizations; to outline FDA's process for the recognition,
rerecognition, suspension and withdrawal of recognition for 3P510k
Review Organizations; and to ensure consistent quality of work among
3P510k Review Organizations through Medical Device User Fee Amendments
IV commitments authorized under FDARA in order to eliminate the need
for routine, substantive re-review by FDA. This guidance also outlines
FDA's current thinking on leveraging the International Medical Device
Regulators Forum's requirements for Regulatory Reviewers under the Good
Regulatory Review Practices and the Medical Device Single Audit
Program.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of September 14, 2018 (83 FR 46742).
FDA revised the
[[Page 14491]]
guidance as appropriate in response to the comments. This guidance
supersedes ``Implementation of Third Party Programs Under the FDA
Modernization Act of 1997; Final Guidance for Staff, Industry, and
Third Parties'' issued on February 2, 2001, and ``Guidance for Third
Parties and FDA Staff; Third Party Review of Premarket Notifications''
issued on September 28, 2004.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the 510(k) Third Party Review Program. 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 statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the 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. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``510(k) Third Party
Review Program'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 17-028 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807............................... Medical Devices: 0910-0375
Third-Party Review
under FDAMA.
807, subpart E.................... Premarket 0910-0120
notification.
``Center for Devices and CDRH Appeals Process 0910-0738
Radiological Health (CDRH)
Appeals Processes''.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
------------------------------------------------------------------------
Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05080 Filed 3-11-20; 8:45 am]
BILLING CODE 4164-01-P
