
[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11204-11206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0145]


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Third Party Review Program: Part I; Draft Guidance for Industry, Food 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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Accreditation and 
Reaccreditation Process for Firms Under the Third Party Review Program: 
Part I.'' The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
amended by the Food and Drug Administration Safety and Innovation Act 
(FDASIA), requires FDA to establish and publish criteria to reaccredit 
or deny reaccreditation to persons accredited by FDA under the FD&C Act 
to perform premarket review of medical devices. This draft guidance 
describes the accreditation, reaccreditation, and accreditation 
withdrawal processes, including criteria that will be considered to 
accredit, reaccredit, deny accreditation to, and deny reaccreditation 
to third party

[[Page 11205]]

reviewers under the Third Party Review Program. The criteria will 
facilitate international harmonization and, thereby, in the future, 
allow us to leverage resources with those of regulating bodies in other 
countries. This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 16, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Accreditation and Reaccreditation Process 
for Firms Under the Third Party Review Program: Part I'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5543, 
Silver Spring, MD 20993, 301-796-6217.

SUPPLEMENTARY INFORMATION: 

I. Background

    The FD&C Act, as amended by FDASIA, requires FDA to establish and 
publish criteria to reaccredit and deny reaccreditation to third 
parties accredited under section 523 of the FD&C Act (21 U.S.C. 360m) 
to perform premarket review of class I and eligible class II premarket 
notification (510(k)) submissions. This draft guidance describes the 
accreditation, reaccreditation, and accreditation withdrawal processes, 
including criteria that will be considered to accredit, reaccredit, 
deny accreditation to, and deny reaccreditation to firms under the 
Third Party Review Program (TPRP).
    The International Medical Device Regulators Forum (IMDRF) recently 
issued a proposed draft document entitled ``Recognition Criteria for 
Medical Device Auditing Organizations'' (IMDRF document), available at 
www.imdrf.org/docs/imdrf/final/consultations/imdrf-mdsap-criteria.pdf. 
The IMDRF was conceived in February 2011 as a forum to discuss future 
directions in medical device regulatory harmonization. It is a 
voluntary group of medical device regulators from around the world, 
which includes 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 (see http://www.imdrf.org).
    The IMDRF draft document reflects the group's effort to develop the 
foundations for a Single Audit Program for medical devices that 
includes criteria for the recognition and rerecognition of third party 
auditing organizations. (The IMDRF document refers to the 
``recognition'' of third parties, whereas the FD&C Act refers to the 
``accreditation'' of third parties.) The IMDRF document includes 
criteria used or proposed by member countries for conformity assessment 
bodies and third party reviewers. The IMDRF also plans to incorporate 
specific requirements for competency and considerations for codes of 
conduct that together will constitute the basis for the recognition of 
third party auditors under a Single Audit Program. When finalized and 
adopted, this document will represent a harmonized standard for 
participating countries and could be useful to FDA to the extent 
consistent with the FD&C Act and other relevant laws and regulations.
    In an effort to develop accreditation and reaccreditation criteria 
that could be used in the future for a harmonized TPRP, in this draft 
guidance we use recognition criteria described in the IMDRF document as 
part of the criteria for third party accreditation by FDA. We intend to 
incorporate information from the IMDRF document in a subsequent draft 
guidance to the extent appropriate as part of the criteria for 
accreditation and reaccreditation of reviewers under the TPRP.
    We plan to update and re-issue this guidance in draft again for 
further comment once the IMDRF has finalized the IMDRF document, which 
is expected to be in December 2013. This guidance does not address 
accreditation of inspectors under the FDA Third Party Inspection 
Program.

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 Agency's current thinking on the 
accreditation and reaccreditation process for firms under the TPRP. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
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 
``Accreditation and Reaccreditation Process for Firms Under the Third 
Party Review Program: Part I,'' you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1815 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the 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 this 
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

[[Page 11206]]

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.
    Accreditation and Reaccreditation Process for Firms Under the Third 
Party Review Program:
    Part I: Draft Guidance for Industry and Food and Drug 
Administration Staff
    This draft guidance describes revised accreditation, new 
reaccreditation, and accreditation withdrawal processes, including 
criteria that will be considered to accredit, reaccredit, deny 
accreditation to, and deny reaccreditation to third party reviewers 
under the TPRP. The guidance provides recommendations regarding the 
information that should be submitted for consideration to accredit and 
reaccredit. This guidance when finalized, will revise the collections 
of information for FDA's Third Party Review Program, OMB control number 
0910-0375.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
  Submission of information for      Number of       Number of     Total annual     burden per
      accreditation program         respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Requests for accreditation                     1               1               1              24              24
 (current requirement)..........
Requests for reaccreditation                   4               1               4              24              96
 (proposed requirement).........
510(k) reviews conducted by                   10              26             260              40          10,400
 accredited third parties
 (current requirement)..........
                                 -------------------------------------------------------------------------------
    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
  Retention of information for       Number of      records per    Total annual     burden per      Total hours
     reaccreditation program       recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews (current                       10              26             260              10           2,600
 requirements)..................
Reaccreditation documentation...              10               1              10              10             100
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           2,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Currently approved collection requirements:
    1. Reporting
    a. Requests for accreditation: In the past 3 years, the Agency has 
averaged receipt of one application for accreditation for third party 
review.
    b. Premarket notification (510(k)) reviews conducted by accredited 
third parties: According to FDA's data in 2009, the Agency has 
experienced that the number of 510(k)s submitted for third-party review 
is approximately 260 annually, which is 26 annual reviews per each of 
the 10 accredited reviewers.
    2. Recordkeeping
    a. Third party reviewers are required to keep records of their 
review of each submission. According to FDA's in 2009, the Agency 
anticipates approximately 260 submissions of 510(k)s for third party 
review per year.
    Proposed revisions to currently approved collection:
1. Reporting
    a. Requests for reaccreditation: The Agency anticipates an average 
receipt of four applications for reaccreditation for third party 
review.
2. Record retention
    a. Record retention related to reaccreditation program: The Agency 
anticipates that there will be a requirement to retain documentation to 
support reaccreditation.
    The respondents for this information collection are private sector, 
for-profit firms seeking accreditation and reaccreditation to 
participate as third party reviewers to review 510(k)s for certain low-
to-moderate risk devices. FDA estimates that it will receive 
approximately four requests for reaccreditation annually. The Agency 
reached this estimate by reviewing the number of existing accredited 
firms under the TPRP program and prorating the reaccreditation of each 
firm every 3 years.
    FDA estimates from past experiences involving the accreditation and 
TPRP processes that requests will take approximately 24 hours per 
respondent. This average is based upon estimates by FDA administrative 
and technical staff who are familiar with the requirements for 
accreditation and reaccreditation under the TPRP. FDA requests comments 
on these estimates and the methodology used to estimate the burdens.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is necessary to send 
only one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03538 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P


