[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46742-46745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19992]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2565]


510(k) Third-Party Review Program; Draft Guidance for Industry, 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the availability of the draft guidance entitled ``510(k) Third-Party 
Review Program; Draft Guidance for Industry, Food and Drug 
Administration Staff, and Third-Party Review Organizations.'' This 
draft guidance provides a comprehensive look into FDA's current 
thinking regarding the 510(k) Third-Party (3P) 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issue draft guidance on the factors that will be used in determining 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 3P Review 
Program is intended to allow review of devices by 3P Review 
Organizations to provide manufacturers of these devices an alternative 
review process that allows FDA to best utilize our resources on higher 
risk devices. This draft guidance is not final nor is it in effect at 
this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 13, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit either electronic or written comments 
on the collection of information by November 13, 2018.

ADDRESSES: You may submit comments on any guidance 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

[[Page 46743]]

made publicly available, submit your comments only as a written/paper 
submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    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 draft guidance document entitled 
``510(k) Third-Party Review Program'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one 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. 5659, 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 
3P Review Program. Under FDARA (Pub. L. 115-52), the criteria used to 
establish device eligibility in the 3P Review Program changed and 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 
objectives of this draft guidance are: (1) To describe the factors FDA 
will use in determining device type eligibility for review by 3P Review 
Organizations; (2) to outline FDA's process for the recognition, re-
recognition, suspension, and withdrawal of recognition for 3P Review 
Organizations; and (3) to ensure consistent quality of work among 3P 
Review Organizations through Medical Device User Fee Amendments IV 
commitments authorized under FDARA. This draft guidance also outlines 
FDA's current thinking on leveraging the International Medical Device 
Regulators Forum's requirements for the Medical Device Single Audit 
Program.
    Upon issuance, this draft guidance will replace the draft guidance 
entitled ``510(k) Third-Party Review Program--Draft Guidance for 
Industry, Food and Drug Administration Staff, and Third-Party Review 
Organizations'' (81 FR 62744) issued on September 12, 2016.
    This draft guidance, when finalized, will supersede 
``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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on 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. This guidance is not subject to Executive 
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 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

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 46744]]

510(k) Third-Party Review Program (Formerly Medical Devices; Third-
Party Review Under the Food and Drug Administration Modernization Act)

OMB Control Number 0910-0375--Revision

    Information collections (ICs) associated with the 510(k) Third-
Party Review Program have been approved under OMB control number 0910-
0375, ``Medical Devices; Third-Party Review Under the Food and Drug 
Administration Modernization Act.'' When finalized, the draft guidance 
entitled ``510(k) Third-Party Review Program; Draft Guidance for 
Industry, Food and Drug Administration Staff, and Third-Party Review 
Organizations'' will necessitate revisions to the burden estimates in 
OMB control number 0910-0375.
    Section 210 of the Food and Drug Administration Modernization Act 
(FDAMA) established section 523 of the 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). Participation in this third-
party 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 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 a period of 3 years.
    Respondents to this information collection are businesses or other 
for-profit organizations.
    FDA estimates the burden of this IC as follows:

Estimated Annual Reporting Burden

    Requests for accreditation (initial): On average, the Agency has 
received one application for accreditation for 3P review per year. 
There is no change to this 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 3P Review Organizations (7) and the frequency of re-recognition (3 
years), we expect to receive approximately 2 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 3P Review 
Organizations. This IC has been adjusted based on current trends, 
however, there is no program change to this IC.
    Complaints: The guidance recommends that the 3P Review Organization 
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
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,952
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.
(15 minutes)

Estimated Annual Recordkeeping Burden

    510(k) Reviews: 3P Review Organizations 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 3P review to be 147 annually; approximately 21 annual 
reviews for each of the 7 3P Review Organizations. 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 3P 
Review Organization: Under section 704(f) of the FD&C Act (21 U.S.C. 
374(f)), a 3P Review Organization must maintain records that support 
their initial and continuing qualifications to receive FDA recognition, 
including documentation of the training and qualifications of the 3P 
Review Organization and its personnel; the procedures used by the 3P 
Review Organization for handling confidential information; the 
compensation arrangements made by the 3P Review Organization; and the 
procedures used by the 3P Review Organization to identify and avoid 
conflicts of interest. Additionally, the draft guidance states that 3P 
Review Organizations 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 3P Review Organization.'' 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)(E)(iv) 
of the FD&C Act requires 3P Review Organizations to agree in writing 
that they will promptly respond and attempt to resolve complaints 
regarding their activities. The draft guidance

[[Page 46745]]

recommends that 3P Review Organizations 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 burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews \3\..............               7              21             147              10           1,470
Records regarding qualifications               7               1               7               1               7
 to receive FDA recognition as a
 3P Review Organization \4\.....
Recordkeeping system regarding                 7               1               7               2              14
 complaints \4\.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,491
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.

    We revised our estimates for OMB control number 0910-0375 by adding 
new ICs, changing the title of the ICR, and adjusting the existing ICs 
based on current trends. Despite the addition of new ICs, the estimated 
burden reflects an overall decrease of 5,581 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 3P 
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 in the 
guidance document ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' have been approved under OMB control number 
0910-0756.

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19992 Filed 9-13-18; 8:45 am]
 BILLING CODE 4164-01-P