[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Pages 62744-62747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21876]


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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510(k) Third Party Review Program; Draft Guidance for Industry, 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``510(k) Third Party Review 
Program.'' This draft guidance provides a comprehensive look into FDA's 
current thinking regarding the 510(k) Third Party (TP) Review Program 
authorized under section 523 of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act). In an effort to encourage harmonization, this guidance 
proposes to refer to, for the purpose of the TP Review Program, where 
appropriate and consistent with the FD&C Act and other applicable laws 
and regulations, the elements from the International Medical Device 
Regulators Forum's regulatory assessment program called the Medical 
Device Single Audit Program. In addition, the Food and Drug 
Administration Safety and Innovation Act (FDASIA) requires FDA to 
establish and publish in the Federal Register criteria to reaccredit 
and deny reaccreditation of TP Review Organizations. Those criteria, 
including others, are described in this draft guidance. This draft 
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 10, 2017. Submit written or electronic comments on 
the collection of information by November 14, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 the draft guidance entitled ``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 http://www.regulations.gov or at the Division of Dockets 
Management 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

[[Page 62745]]

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 http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 (TP) 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: Stacy Cho, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5625, Silver Spring, MD 20993, 240-402-6158.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the TP Review Program is to implement section 523 of 
the FD&C Act (21 U.S.C. 360m). Section 523 authorizes FDA to accredit 
third parties to review premarket notification (510(k)) submissions and 
recommend the initial classification of certain devices. FDA's 
implementation of section 523 includes establishing a process of 
recognition of qualified third parties to conduct the initial review of 
510(k) submissions for certain low-to-moderate risk devices eligible 
under the TP Review Program (formerly known as the Accredited Persons 
Program). The TP Review Program is intended to allow review of such 
devices by TP Review Organizations in order to provide manufacturers of 
these devices an alternative review process that may yield more rapid 
510(k) decisions. TP Review Organizations conduct the equivalent of an 
FDA premarket review of a 510(k) submission, and then forward their 
reviews, recommendations, and 510(k) submissions to FDA for a decision 
concerning the substantial equivalence of a device.
    In February 2011, the International Medical Device Regulators Forum 
(IMDRF) was conceived to discuss future directions in medical device 
regulatory harmonization. The IMDRF is a voluntary group of medical 
device regulators from around the world, including representatives from 
the FDA, who have come together to build on the strong foundational 
work of the Global Harmonization Task Force on Medical Devices. The 
purpose of the IMDRF is to accelerate international medical device 
regulatory harmonization and convergence.
    As one of its initial actions, the IMDRF developed the regulatory 
assessment program called the Medical Device Single Audit Program 
(MDSAP), which is outlined in a collection of documents (Ref. 1). The 
IMDRF MDSAP documents provide the fundamental building blocks of an 
auditing program by providing a common set of criteria to be utilized 
for the recognition and monitoring of entities that perform regulatory 
audits and other related functions.
    In an effort to encourage harmonization, this draft guidance refers 
to the standards described in the IMDRF MDSAP documents as criteria FDA 
will consider for recognition, rerecognition, recognition denial, 
rerecognition denial, and recognition withdrawal of TP Review 
Organizations under the TP Review Program. In addition, the draft 
guidance does not use those statutory terms found under section 523 of 
the FD&C Act such as accredited persons, accredit, or reaccredit, but 
defines such terms as third party review organizations, recognition, 
and rerecognition as synonymous terms. FDA appreciates the advantages 
of harmonized international standards, and FDA believes that, when 
finalized, this guidance document will help to further bring the TP 
Review Program into harmony with such standards, as well as provide 
clarity and consistency for industry.
    In addition, the goal of this draft guidance is to provide FDA's 
current thinking on the TP Review Program in the following areas: (1) 
TP Review Organizations review of 510(k) submissions; (2) requirements 
and recommendations for recognition and rerecognition of TP Review 
Organizations under the TP Review Program; (3) content and format of a 
TP Review Organization's application for initial recognition and 
rerecognition; and (4) suspension or withdrawal of recognition. 
Further, section 611 of FDASIA (Pub. L. 112-144) requires FDA to 
establish and publish in the Federal Register criteria to reaccredit 
and deny reaccreditation of TP Review Organizations. Those criteria are 
described in this draft guidance and if finalized, the guidance will 
represent FDA's implementation of section 611 of FDASIA.
    Upon issuance, this draft guidance will replace the draft guidance 
entitled ``Accreditation and Reaccreditation Process for Firms under 
the Third Party Review Program: Part I--Draft Guidance for Industry, 
Food and Drug Administration Staff, and Third Party Reviewers'' issued 
on February 15, 2013 (Ref. 2).

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 
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 draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
the draft guidance entitled ``510(k) Third Party Review Program,'' you 
may either send an email request to

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[email protected] to receive an electronic copy of the 
document. Please use the document number 1500013 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3502), 
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.

Medical Devices; Third-Party Review Under FDAMA

OMB Control Number 0910-0375--Revision
    This draft guidance describes the recognition, rerecognition, 
recognition/rerecognition denial, and recognition withdrawal processes, 
including criteria that will be considered for such processes under the 
TP Review Program. The draft guidance provides how TP Review 
Organizations can apply for recognition and rerecognition, as well as 
describes the information to be kept, maintained, and submitted to FDA 
for the purpose of TP review. The guidance, when finalized, will revise 
the collections of information for FDA's Third Party Review Program, 
OMB control 0910-0375. For clarity, we also propose to revise the title 
of the information collection to ``Third Party Review Program for 
Medical Device Premarket Notification.'' Additionally, to be consistent 
with the guidance, we propose to revise OMB control number 0910-0375 to 
use the terms recognition, rerecognition, recognition/rerecognition 
denial, and recognition withdrawal to refer to the process of 
accreditation, reaccreditation, accreditation/reaccreditation denial, 
and withdrawal of accreditation under section 523 of the FD&C Act.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Requests for recognition                       1               1               1              24              24
 (current approval).............
Requests for rerecognition                     4               1               4              24              96
 (proposed).....................
510(k) reviews conducted by                   10              26             260              40          10,400
 recognized third party review
 organizations (current
 approval)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                    Table 2--Estimated Annual Recordkeeping Burden 1
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                                                                                      Number of                        Average burden
                                                                    Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews (current approval).............................                10                26               260                10             2,600
Recognition/Rerecognition documentation (proposed)............                10                 1                10                10               100
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................              2700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates from past experiences regarding the recognition and 
rerecognition processes that the application will take approximately 24 
hours per respondent. This average is based upon estimates by FDA 
administrative and technical staff that are familiar with the 
recognition and rerecognition processes under the TP Review Program. 
FDA requests comments on these estimates and the methodology used to 
estimate the burdens.
    Currently approved information collection:
 Reporting

    [cir] Requests for recognition: In the past 3 years, the Agency has 
averaged receipt of 1 application for recognition for third party 
510(k) review.
    [cir] 510(k) reviews conducted by recognized TP Review 
Organizations: According to FDA's data in 2009, the number of 510(k)s 
submitted for third party review is approximately 260 annually, which 
is on average 26 annual 510(k) reviews per each of the 10 recognized TP 
Review Organizations.

 Recordkeeping

    [cir] TP Review Organizations are expected to keep and maintain 
records related to their review of 510(k) submissions. According to 
2009 data, the Agency anticipates approximately

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260 submissions of 510(k)s for third party review per year.
    Proposed revisions to the currently approved information 
collection:

 Reporting

    [cir] Requests for rerecognition: The Agency anticipates an average 
annual receipt of four applications for rerecognition for third party 
510(k) review. The Agency reached this estimate by reviewing the number 
of existing recognized firms under the TP Review Program and 
anticipating the number of firms applying for rerecognition every 3 
years.

 Recordkeeping

    [cir] The Agency expects TP Review Organizations to retain and 
maintain documentation related to recognition and rerecognition.
    The respondents for this information collection are private sector, 
for-profit firms seeking recognition and rerecognition.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 807, subpart E have been approved under OMB control 
number 0910-0120; collections of information for the device appeals 
processes have been approved under OMB control number 0910-0738.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the 
date this document publishes in the Federal Register but Web sites are 
subject to change over time.

    1. International Medical Device Regulators Forum's Medical 
Device Single Audit Program documents, available at http://imdrf.org/documents/documents.asp.
    2. FDA Draft Guidance entitled ``Accreditation and 
Reaccreditation Process for Firms under the Third Party Review 
Program: Part I,'' February 15, 2013, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339697.pdf.

    Dated: September 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21876 Filed 9-9-16; 8:45 am]
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