[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]


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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.

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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\
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                                                     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
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\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]
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