[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11204-11206]
From the Federal Register Online via the Government Publishing 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Third Party Review Program: Part I; Draft Guidance for Industry, Food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availability of the draft guidance entitled ``Accreditation and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 This draft guidance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 This draft guidance is not final nor is it in effect at this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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 16, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Accreditation and Reaccreditation Process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
[email protected] 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)
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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)..........
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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
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510(k) reviews (current 10 26 260 10 2,600
requirements)..................
Reaccreditation documentation... 10 1 10 10 100
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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