Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program, 55155-55158 [2019-22345]
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; ACF
Performance Progress Report, ACF–
OGM–SF–PPR–B
Office of Grants Management,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Grants
Management (OGM), in the
Administration for Children and
Families (ACF) is requesting a 3-year
extension of the form ACF–OGM–SF–
PPR–B (OMB #0970–0406, expiration 9/
30/2019). There are no changes
requested to the form.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
SUMMARY:
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained 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, 330 C Street, SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The ACF Office of Grants
Management proposes to continue
55155
collecting program performance data for
ACF’s discretionary grantees using the
existing ACF–OGM–SF–PPR–B (OMB
#0970–0406, expiration 9/30/2019) form
with no changes. The form, developed
by OGM, was created from the basic
template of the OMB-approved
reporting format of the Program
Performance Report. OGM uses this data
to ensure grantees are proceeding in a
satisfactory manner in meeting the
approved goals and objectives of the
project, and if funding should be
continued for another budget period.
The requirement for grantees to report
on performance is OMB grants policy.
Specific citations are contained in 45
CFR part 75 Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements for HHS Awards.
Respondents: All ACF Discretionary
Grantees. State governments, Native
American Tribal governments, Native
American Tribal Organizations, Local
Governments, and Nonprofits with or
without 501(c)(3) status with the IRS.
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
ACF–OGM–SF–PPR–B .......................................................
6,000
6
1
36,000
12,000
Estimated Total Annual Burden
Hours: 12,000.
(Authority: 45 CFR part 75).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–22343 Filed 10–11–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2565]
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 510(k) Third-Party
Review Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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16:25 Oct 11, 2019
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(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
14, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0375. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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510(k) Third-Party Review Program
OMB Control Number 0910–0375—
Extension With Revision
Information collections (ICs)
associated with the 510(k) third-party
(3P510k) review program have been
approved under OMB control number
0910–0375. We request extension,
including revisions, of the information
collection approval as described in this
document.
Section 210 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) established section 523
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360m),
directing FDA to accredit persons in the
private sector to review certain
premarket notifications (510(k)s; see 21
U.S.C. 360(k)). Participation in the
3P510k review program by accredited
persons is entirely voluntary. A third
party wishing to participate will submit
a request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
reviewer’s documented review and
recommendation, to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually 3 years.
Respondents to this information
collection are businesses or other forprofit organizations.
In the Federal Register of September
14, 2018 (83 FR 46742), FDA announced
the availability of the draft guidance
entitled ‘‘510(k) Third-Party Review
Program; Draft Guidance for Industry,
Food and Drug Administration Staff,
and Third-Party Review Organizations.’’
The draft guidance was intended to
provide a comprehensive look into
FDA’s current thinking regarding the
3P510k review program authorized
under the FD&C Act. Under the FDA
Reauthorization Act of 2017, FDA was
directed to issue draft 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
third-party 510k review organizations
(3PROs) to provide manufacturers of
these devices an alternative review
process that allows FDA to best utilize
our resources on higher risk devices.
The September 14, 2018, notice
requested comment on the draft
guidance and related revision of the
information collection in OMB control
number 0910–0375. We describe and
respond below to the comments related
to the information collection. We have
numbered each comment to help
distinguish between different
comments. We have grouped similar
comments together under the same
number, and, in some cases, we have
separated different issues discussed in
the same comment and designated them
as distinct comments for purposes of
our responses. The number assigned to
each comment or comment topic is
purely for organizational purposes and
does not signify the comment’s value or
importance or the order in which
comments were received.
(Comment 1) One comment suggested
that the 3P510k review program reduces
the burden for FDA staff and industry
and increases the burden on patients
and doctors to figure out which devices
are safe and which are not.
Another comment suggested that FDA
has not demonstrated that its proposed
changes to the 3P510k review program
will benefit patients and that the 3P510k
review program reduces patient safety,
rather than protecting patients from
potentially harmful devices.
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(Response 1) FDA disagrees with
these comments. Section 523 of the
FD&C Act requires FDA to accredit
persons for the purpose of reviewing
reports submitted under section 510(k)
of the FD&C Act and making a
recommendation to FDA. All devices
subject to the 510(k) requirements,
including devices cleared through the
3P510k review program, must
demonstrate substantial equivalence to a
legally marketed device prior to
introduction into interstate commerce
(see 21 U.S.C. 360(k), 360(n), 360c(f)(1)
and 360c(i); 21 CFR 807.92(a)(3)). Under
the 3P510k review program, the
objective is for the 3PRO to provide a
review equivalent to that of an FDA
reviewer, including making a
recommendation, which it submits to
FDA. FDA reviews that information to
make a final determination of
substantial equivalence and where
appropriate, FDA will limit its review to
a supervisory-level review. Therefore,
the burden to demonstrate substantial
equivalence remains unchanged.
In addition, this guidance describes
the factors FDA will use to ensure only
appropriate device types are eligible for
the 3P510k review program and benefits
the public health by allowing new, lowto-moderate risk devices to obtain FDAequivalent review while enabling FDA
to focus more resources on higher risk
and more complex devices that
necessitate more rigorous review
benefitting the public health.
Accordingly, no change to the guidance
is necessary.
(Comment 2) One comment suggested
that the proposed definition of a 510(k)
Submitter is too narrow by referring to
‘‘scientific and technical data’’ and
should be revised to reflect the
additional components of a 510(k)
submission, such as intended use.
(Response 2) FDA agrees that a 510(k)
submission can include more than
scientific and technical data. Rather
than trying to define the appropriate
components of a 510(k) submission in
this guidance, FDA has modified the
definition of 510(k) Submitter by
removing reference to submitting
‘‘scientific and technical data.’’
(Comment 3) One comment requested
clarification regarding to whom the
3PROs should provide copies of written
communications between the 510(k)
submitter and the 3PRO and, if these
copies are submitted to FDA, that this
is unnecessarily burdensome to both the
510(k) submitter and the 3PRO.
(Response 3) FDA agrees that this
language should be, and therefore it has
been, clarified as FDA’s intent was that
these communications would be
provided to FDA and that the context of
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these communications is the
communication and response to
deficiencies in the submission.
However, FDA disagrees that providing
the Agency this information is
unnecessarily burdensome. FDA
believes that to understand and evaluate
whether the 3PRO conducted an FDAequivalent review, it is necessary to
understand how the 3PRO documented
and communicated any deficiencies it
found during its review, how the 510(k)
submitter responded to those
deficiencies, and how the 3PRO
evaluated those responses.
(Comment 4) Several comments
suggested that the language in the
guidance is unclear as to whether the
510(k) submitter should provide the
3PRO with all subsequent
correspondence that the submitter has
with FDA and that once a 3PRO has
submitted its recommendation to FDA
that any substantive interactions
between FDA and the 510(k) submitter
are not always relevant and any
mandate to supply such correspondence
creates additional burden.
Additionally, a comment requested
clarification regarding to whom the
3PRO should provide a copy of all
written communications.
(Response 4) To the extent that the
commenter refers to subsequent
correspondence on the 510(k)
submission in question, FDA disagrees
with the comment. The 3PRO’s
responsibilities to provide an FDAequivalent review do not end with the
initial submission to FDA. As discussed
in subsection VI.J of the guidance, FDA
will contact the 3PRO by telephone or
email if additional information is
needed. FDA not only expects the 3PRO
to communicate with the 510(k)
submitter to resolve any issues needing
the submitter’s input, FDA also expects
the 3PRO to thoroughly evaluate any
responses received and to document
those in its updated review memo.
Therefore, the 3PRO should be involved
in any discussions between FDA and
the 510(k) submitter regarding the
request for additional information. FDA
does not believe that the continued
involvement of the 3PRO creates an
unnecessary burden given their
responsibilities, whereas their
involvement in those discussions
ensures the response is evaluated in a
timely and efficient manner.
(Comment 5) One comment requested
clarification on what a new review
memo provided by a 3PRO in response
to FDA’s request for additional
information should include or whether
a documented evaluation result
referring to the evaluation of the 510(k)
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
submitter’s responses to FDA’s request
for additional information is sufficient.
(Response 5) FDA has clarified in the
final guidance that the initial review
memo provided by the 3PRO should be
updated with this new information in
response to FDA’s request for additional
information. This is consistent with
FDA’s expectation that the 3PRO
provide a review equivalent to that of an
FDA reviewer.
FDA estimates the burden of this
collection of information as follows:
Estimated Annual Reporting Burden
Requests for accreditation (initial): On
average, the Agency has received one
application for accreditation for 3P510k
review per year. There is no change to
this information collection (IC) from the
currently approved burden estimate.
Requests for accreditation (rerecognition): We have added an IC for
re-recognition requests to be consistent
with the guidance, which states that
requests for re-recognition will be
handled in the same manner as initial
recognition requests. Based on the
estimated number of 3PROs (seven) and
the frequency of re-recognition (3 years),
we expect to receive approximately two
re-recognition requests per year. We
expect the average burden per response
to be the same as an initial request (24
hours).
510(k) reviews conducted by
accredited third parties: Based on FDA’s
recent experience with this program, we
estimate the number of 510(k)s
submitted for third-party review to be
147 annually; approximately 21 annual
reviews for each of the 7 3PROs. This
IC has been adjusted based on current
trends, however, there is no program
change to this IC.
Complaints: The guidance
recommends that the 3PRO should
forward to FDA information on any
complaint (e.g., whistleblowing) it
receives about a 510(k) submitter that
could indicate an issue related to the
safety or effectiveness of a medical
device or a public health risk. Therefore,
we have added an IC for complaints to
the reporting burden. We expect to
receive one forwarded complaint per
year. Based on similar information
collections, we estimate the average
burden per complaint to be 0.25 hours
(15 minutes).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours 2
Requests for accreditation (initial) 3 .....................................
Requests for accreditation (re-recognition) 5 .......................
510(k) reviews conducted by accredited third parties 4 .......
Complaints 5 .........................................................................
1
2
7
1
1
1
21
1
1
2
147
1
24
24
40
0.25
24
48
5,880
1
Total ..............................................................................
........................
........................
........................
........................
5,953
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Totals have been rounded.
3 There is no change to this IC from the currently approved burden estimate.
4 This IC has been adjusted based on current trends, however, there is no program change to this IC.
5 This IC revises OMB control number 0910–0375 to reflect the draft guidance entitled ‘‘510(k) Third Party Review Program; Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.’’
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Estimated Annual Recordkeeping
Burden
510(k) reviews: The 3PROs should
retain copies of all 510(k) reviews and
associated correspondence. Based on
FDA’s recent experience with this
program, we estimate the number of
510(k)s submitted for 3P510k review to
be 147 annually; approximately 21
annual reviews for each of the 7 3PROs.
We estimate the average burden per
recordkeeping to be 10 hours. The
estimated number of records and
recordkeepers have been adjusted based
on current trends, however, there is no
program change to this IC.
Records regarding qualifications to
receive FDA recognition as a 3PRO:
Under section 704(f) of the FD&C Act
(21 U.S.C. 374(f)), a 3PRO must
maintain records that support their
initial and continuing qualifications to
receive FDA recognition, including
documentation of the training and
qualifications of the 3PRO and its
personnel; the procedures used by the
3P510k review organization for
handling confidential information; the
compensation arrangements made by
the 3PRO; and the procedures used by
the 3PRO to identify and avoid conflicts
of interest. Additionally, the draft
guidance states that 3PROs should
retain information on the identity and
qualifications of all personnel who
contributed to the technical review of
each 510(k) submission and other
relevant records. Therefore, we have
added an IC for ‘‘Records regarding
qualification to receive FDA recognition
as a 3PRO.’’ Because most of the burden
of compiling the records is expressed in
the reporting burden for requests for
accreditation, we estimate the
maintenance of such records to be 1
hour per recordkeeping annually.
Recordkeeping system regarding
complaints: Section 523(b)(3)(F)(iv) of
the FD&C Act requires 3PROs to agree
in writing that they will promptly
respond and attempt to resolve
complaints regarding their activities.
The guidance recommends that 3PROs
establish a recordkeeping system for
tracking the submission of those
complaints and how those complaints
were resolved, or attempted to be
resolved. Therefore, we have added an
IC for ‘‘Recordkeeping system regarding
complaints.’’ Based on our experience
with the program and the
recommendations in the guidance, we
estimate the average burden per
recordkeeping to be 2 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
510(k) reviews 2 ...................................................................
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Number of
records per
recordkeeper
7
Fmt 4703
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Total annual
records
21
E:\FR\FM\15OCN1.SGM
147
15OCN1
Average
burden per
recordkeeping
10
Total hours
1,470
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Records regarding qualifications to receive FDA recognition as a 3PRO 3 ..............................................................
Recordkeeping system regarding complaints 3 ...................
7
7
1
1
7
7
1
2
7
14
Total ..............................................................................
........................
........................
........................
........................
1,491
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
This IC has been adjusted based on current trends, however, there is no program change to this IC.
3 This IC revises OMB control number 0910–0375 to reflect the draft guidance entitled ‘‘510(k) Third Party Review Program; Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.’’
2
We revised our estimates for OMB
control number 0910–0375 by adding
new ICs, changing the title of the IC
request, and adjusting the existing ICs
based on current trends. Despite the
addition of new ICs, the estimated
burden reflects an overall decrease of
5,580 hours. We attribute this
adjustment to a decrease in the number
of submissions we received over the last
few years.
The draft guidance also refers to
previously approved ICs found in FDA
regulations. The ICs in 21 CFR part 807,
subpart E have been approved under
OMB control number 0910–0120; the
ICs regarding 3P510k review of medical
devices under FDAMA have been
approved under OMB control number
0910–0375; the ICs for the device
appeals processes have been approved
under OMB control number 0910–0738;
the ICs for the Q-Submission Program
(Requests for Feedback on Medical
Device Submissions) have been
approved under OMB control number
0910–0756.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22345 Filed 10–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1021]
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Notice to Public of Website Location of
Center for Devices and Radiological
Health Fiscal Year 2020 Proposed
Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the website location where
the Agency will post two lists of
SUMMARY:
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guidance documents that the Center for
Devices and Radiological Health (CDRH
or the Center) intends to publish in
fiscal year (FY) 2020. In addition, FDA
has established a docket where
interested persons may comment on the
priority of topics for guidance, provide
comments and/or propose draft
language for those topics, suggest topics
for new or different guidance
documents, comment on the
applicability of guidance documents
that have issued previously, and
provide any other comments that could
benefit the CDRH guidance program and
its engagement with stakeholders. This
feedback is critical to the CDRH
guidance program to ensure that we
meet stakeholder needs.
DATES: Submit either electronic or
written comments by December 16,
2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 16, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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,
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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–
2012–N–1021 for ‘‘Notice to Public of
website Location of CDRH Fiscal Year
2020 Proposed Guidance Development.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
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]]>Agencies
[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Notices]
[Pages 55155-55158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2565]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 510(k) Third-Party
Review Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 14, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0375.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
510(k) Third-Party Review Program
OMB Control Number 0910-0375--Extension With Revision
Information collections (ICs) associated with the 510(k) third-
party (3P510k) review program have been approved under OMB control
number 0910-0375. We request extension, including revisions, of the
information collection approval as described in this document.
Section 210 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) established section 523 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360m), directing FDA to accredit
persons in the private sector to review certain premarket notifications
(510(k)s; see 21 U.S.C. 360(k)). Participation in the 3P510k review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to FDA.
Accredited third-party reviewers have the ability to review a
manufacturer's 510(k) submission for selected devices. After reviewing
a submission, the reviewer will forward a copy of the 510(k)
submission, along with the
[[Page 55156]]
reviewer's documented review and recommendation, to FDA. Third-party
reviewers should maintain records of their 510(k) reviews and a copy of
the 510(k) for a reasonable period of time, usually 3 years.
Respondents to this information collection are businesses or other
for-profit organizations.
In the Federal Register of September 14, 2018 (83 FR 46742), FDA
announced the availability of the draft guidance entitled ``510(k)
Third-Party Review Program; Draft Guidance for Industry, Food and Drug
Administration Staff, and Third-Party Review Organizations.'' The draft
guidance was intended to provide a comprehensive look into FDA's
current thinking regarding the 3P510k review program authorized under
the FD&C Act. Under the FDA Reauthorization Act of 2017, FDA was
directed to issue draft 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 third-
party 510k review organizations (3PROs) to provide manufacturers of
these devices an alternative review process that allows FDA to best
utilize our resources on higher risk devices.
The September 14, 2018, notice requested comment on the draft
guidance and related revision of the information collection in OMB
control number 0910-0375. We describe and respond below to the comments
related to the information collection. We have numbered each comment to
help distinguish between different comments. We have grouped similar
comments together under the same number, and, in some cases, we have
separated different issues discussed in the same comment and designated
them as distinct comments for purposes of our responses. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which comments were received.
(Comment 1) One comment suggested that the 3P510k review program
reduces the burden for FDA staff and industry and increases the burden
on patients and doctors to figure out which devices are safe and which
are not.
Another comment suggested that FDA has not demonstrated that its
proposed changes to the 3P510k review program will benefit patients and
that the 3P510k review program reduces patient safety, rather than
protecting patients from potentially harmful devices.
(Response 1) FDA disagrees with these comments. Section 523 of the
FD&C Act requires FDA to accredit persons for the purpose of reviewing
reports submitted under section 510(k) of the FD&C Act and making a
recommendation to FDA. All devices subject to the 510(k) requirements,
including devices cleared through the 3P510k review program, must
demonstrate substantial equivalence to a legally marketed device prior
to introduction into interstate commerce (see 21 U.S.C. 360(k), 360(n),
360c(f)(1) and 360c(i); 21 CFR 807.92(a)(3)). Under the 3P510k review
program, the objective is for the 3PRO to provide a review equivalent
to that of an FDA reviewer, including making a recommendation, which it
submits to FDA. FDA reviews that information to make a final
determination of substantial equivalence and where appropriate, FDA
will limit its review to a supervisory-level review. Therefore, the
burden to demonstrate substantial equivalence remains unchanged.
In addition, this guidance describes the factors FDA will use to
ensure only appropriate device types are eligible for the 3P510k review
program and benefits the public health by allowing new, low-to-moderate
risk devices to obtain FDA-equivalent review while enabling FDA to
focus more resources on higher risk and more complex devices that
necessitate more rigorous review benefitting the public health.
Accordingly, no change to the guidance is necessary.
(Comment 2) One comment suggested that the proposed definition of a
510(k) Submitter is too narrow by referring to ``scientific and
technical data'' and should be revised to reflect the additional
components of a 510(k) submission, such as intended use.
(Response 2) FDA agrees that a 510(k) submission can include more
than scientific and technical data. Rather than trying to define the
appropriate components of a 510(k) submission in this guidance, FDA has
modified the definition of 510(k) Submitter by removing reference to
submitting ``scientific and technical data.''
(Comment 3) One comment requested clarification regarding to whom
the 3PROs should provide copies of written communications between the
510(k) submitter and the 3PRO and, if these copies are submitted to
FDA, that this is unnecessarily burdensome to both the 510(k) submitter
and the 3PRO.
(Response 3) FDA agrees that this language should be, and therefore
it has been, clarified as FDA's intent was that these communications
would be provided to FDA and that the context of these communications
is the communication and response to deficiencies in the submission.
However, FDA disagrees that providing the Agency this information is
unnecessarily burdensome. FDA believes that to understand and evaluate
whether the 3PRO conducted an FDA-equivalent review, it is necessary to
understand how the 3PRO documented and communicated any deficiencies it
found during its review, how the 510(k) submitter responded to those
deficiencies, and how the 3PRO evaluated those responses.
(Comment 4) Several comments suggested that the language in the
guidance is unclear as to whether the 510(k) submitter should provide
the 3PRO with all subsequent correspondence that the submitter has with
FDA and that once a 3PRO has submitted its recommendation to FDA that
any substantive interactions between FDA and the 510(k) submitter are
not always relevant and any mandate to supply such correspondence
creates additional burden.
Additionally, a comment requested clarification regarding to whom
the 3PRO should provide a copy of all written communications.
(Response 4) To the extent that the commenter refers to subsequent
correspondence on the 510(k) submission in question, FDA disagrees with
the comment. The 3PRO's responsibilities to provide an FDA-equivalent
review do not end with the initial submission to FDA. As discussed in
subsection VI.J of the guidance, FDA will contact the 3PRO by telephone
or email if additional information is needed. FDA not only expects the
3PRO to communicate with the 510(k) submitter to resolve any issues
needing the submitter's input, FDA also expects the 3PRO to thoroughly
evaluate any responses received and to document those in its updated
review memo. Therefore, the 3PRO should be involved in any discussions
between FDA and the 510(k) submitter regarding the request for
additional information. FDA does not believe that the continued
involvement of the 3PRO creates an unnecessary burden given their
responsibilities, whereas their involvement in those discussions
ensures the response is evaluated in a timely and efficient manner.
(Comment 5) One comment requested clarification on what a new
review memo provided by a 3PRO in response to FDA's request for
additional information should include or whether a documented
evaluation result referring to the evaluation of the 510(k)
[[Page 55157]]
submitter's responses to FDA's request for additional information is
sufficient.
(Response 5) FDA has clarified in the final guidance that the
initial review memo provided by the 3PRO should be updated with this
new information in response to FDA's request for additional
information. This is consistent with FDA's expectation that the 3PRO
provide a review equivalent to that of an FDA reviewer.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
Requests for accreditation (initial): On average, the Agency has
received one application for accreditation for 3P510k review per year.
There is no change to this information collection (IC) from the
currently approved burden estimate.
Requests for accreditation (re-recognition): We have added an IC
for re-recognition requests to be consistent with the guidance, which
states that requests for re-recognition will be handled in the same
manner as initial recognition requests. Based on the estimated number
of 3PROs (seven) and the frequency of re-recognition (3 years), we
expect to receive approximately two re-recognition requests per year.
We expect the average burden per response to be the same as an initial
request (24 hours).
510(k) reviews conducted by accredited third parties: Based on
FDA's recent experience with this program, we estimate the number of
510(k)s submitted for third-party review to be 147 annually;
approximately 21 annual reviews for each of the 7 3PROs. This IC has
been adjusted based on current trends, however, there is no program
change to this IC.
Complaints: The guidance recommends that the 3PRO should forward to
FDA information on any complaint (e.g., whistleblowing) it receives
about a 510(k) submitter that could indicate an issue related to the
safety or effectiveness of a medical device or a public health risk.
Therefore, we have added an IC for complaints to the reporting burden.
We expect to receive one forwarded complaint per year. Based on similar
information collections, we estimate the average burden per complaint
to be 0.25 hours (15 minutes).
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response \2\
----------------------------------------------------------------------------------------------------------------
Requests for accreditation 1 1 1 24 24
(initial) \3\..................
Requests for accreditation (re- 2 1 2 24 48
recognition) \5\...............
510(k) reviews conducted by 7 21 147 40 5,880
accredited third parties \4\...
Complaints \5\.................. 1 1 1 0.25 1
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 5,953
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals have been rounded.
\3\ There is no change to this IC from the currently approved burden estimate.
\4\ This IC has been adjusted based on current trends, however, there is no program change to this IC.
\5\ This IC revises OMB control number 0910-0375 to reflect the draft guidance entitled ``510(k) Third Party
Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations.''
Estimated Annual Recordkeeping Burden
510(k) reviews: The 3PROs should retain copies of all 510(k)
reviews and associated correspondence. Based on FDA's recent experience
with this program, we estimate the number of 510(k)s submitted for
3P510k review to be 147 annually; approximately 21 annual reviews for
each of the 7 3PROs. We estimate the average burden per recordkeeping
to be 10 hours. The estimated number of records and recordkeepers have
been adjusted based on current trends, however, there is no program
change to this IC.
Records regarding qualifications to receive FDA recognition as a
3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO
must maintain records that support their initial and continuing
qualifications to receive FDA recognition, including documentation of
the training and qualifications of the 3PRO and its personnel; the
procedures used by the 3P510k review organization for handling
confidential information; the compensation arrangements made by the
3PRO; and the procedures used by the 3PRO to identify and avoid
conflicts of interest. Additionally, the draft guidance states that
3PROs should retain information on the identity and qualifications of
all personnel who contributed to the technical review of each 510(k)
submission and other relevant records. Therefore, we have added an IC
for ``Records regarding qualification to receive FDA recognition as a
3PRO.'' Because most of the burden of compiling the records is
expressed in the reporting burden for requests for accreditation, we
estimate the maintenance of such records to be 1 hour per recordkeeping
annually.
Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv)
of the FD&C Act requires 3PROs to agree in writing that they will
promptly respond and attempt to resolve complaints regarding their
activities. The guidance recommends that 3PROs establish a
recordkeeping system for tracking the submission of those complaints
and how those complaints were resolved, or attempted to be resolved.
Therefore, we have added an IC for ``Recordkeeping system regarding
complaints.'' Based on our experience with the program and the
recommendations in the guidance, we estimate the average burden per
recordkeeping to be 2 hours.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews \2\.............. 7 21 147 10 1,470
[[Page 55158]]
Records regarding qualifications 7 1 7 1 7
to receive FDA recognition as a
3PRO \3\.......................
Recordkeeping system regarding 7 1 7 2 14
complaints \3\.................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 1,491
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This IC has been adjusted based on current trends, however, there is no program change to this IC.
\3\ This IC revises OMB control number 0910-0375 to reflect the draft guidance entitled ``510(k) Third Party
Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations.''
We revised our estimates for OMB control number 0910-0375 by adding
new ICs, changing the title of the IC request, and adjusting the
existing ICs based on current trends. Despite the addition of new ICs,
the estimated burden reflects an overall decrease of 5,580 hours. We
attribute this adjustment to a decrease in the number of submissions we
received over the last few years.
The draft guidance also refers to previously approved ICs found in
FDA regulations. The ICs in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the ICs regarding 3P510k
review of medical devices under FDAMA have been approved under OMB
control number 0910-0375; the ICs for the device appeals processes have
been approved under OMB control number 0910-0738; the ICs for the Q-
Submission Program (Requests for Feedback on Medical Device
Submissions) have been approved under OMB control number 0910-0756.
Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22345 Filed 10-11-19; 8:45 am]
BILLING CODE 4164-01-P
