[Federal Register: June 3, 2004 (Volume 69, Number 107)]
[Notices]
[Page 31397-31398]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn04-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0251]
Draft Guidance for Industry, Food and Drug Administration Staff,
and Food and Drug Administration-Accredited Third-Parties: Requests for
Inspection by an Accredited Person Under the Inspections by Accredited
Persons Program Authorized by the Medical Device User Fee and
Modernization Act of 2002; 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availability of the draft guidance entitled ``Requests for Inspection
by an Accredited Person Under the Inspections by Accredited Persons
Program Authorized by Section 201 of the Medical Device User Fee and
Modernization Act of 2002.'' Section 201 of the Medical Device User Fee
and Modernization Act of 2002 (MDUFMA) authorizes FDA-accredited third
parties (accredited persons or APs) to conduct inspections of
manufacturers of class II and class III devices who meet certain
eligibility criteria as defined by the statute. This draft guidance
document describes the establishment eligibility criteria and the
process for establishments to follow when requesting FDA's approval to
have an AP conduct an inspection of their establishment instead of FDA
under the new inspections by accredited persons program (AP program).
DATES: Submit written or electronic comments on this draft guidance by
September 1 2004. Submit comments on the collection of information by
August 2, 2004.
ADDRESSES: Submit written requests for single copies on a
3.5 diskette of the guidance document entitled ``Requests
for Inspection Under the Inspection by Accredited Persons Program
Authorized by Section 201 of the Medical Device User Fee and
Modernization Act of 2002'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to
assist that office in processing your request, or fax your request to
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit written comments on the guidance and collection of
information to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments on the guidance and collection of
information to: http://www.fda.gov/dockets/ecomments. Identify all
comments with the docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT:
For medical device issues: Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ-300), Food and Drug Administration, 2098
Gaither Road, Rockville, MD 20850 301-594-4692
For biologics issues: Carol Rehkopf, Center for Biologics
Evaluation and Research (HFM-650) Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852 301-827-6202
SUPPLEMENTARY INFORMATION:
I. Background
MDUFMA (Public Law 107-250) added a provision in section 704(g) to
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374(g))
to permit third-party inspections of eligible establishments who market
class II or class III devices in the United States and who also market
or plan to market such devices in foreign countries. The new law also
defines the qualifying criteria that a manufacturer must meet in order
to participate in the AP program (section 704(g)(6)(A) of the act).
This guidance will help manufacturers determine whether they are
eligible to participate in this inspectional program and identifies the
information manufacturers should submit to the agency when requesting
permission to use an AP.
The AP program generally enables manufactures to better manage
their inspection schedules since they will schedule the AP inspections
themselves, provided FDA has approved their request to use an AP.
Eligible firms, however, remain subject to inspections by FDA (section
704(g)(9) of the act). The program is voluntary; no manufacturer is
required to participate, whether domestic or foreign.
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 agency's current thinking on inspection requests under
the AP program authorized by section 201 of MDUFMA. 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. Comments
Interested parties may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
IV. Electronic Access
To receive ``Requests for Inspection under the Inspection by
Accredited Persons Program Authorized by Section 201 of the Medical
Device User Fee and Modernization Act of 2002'' by fax machine, call
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a
touch-tone telephone. Press 1 to enter the system. At the second voice
prompt, press 1 to order a document. Enter the document number 1532
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of cleared submissions, approved applications, and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic
[[Page 31398]]
submissions, Mammography Matters, and other device-oriented
information. The CDRH Internet may be accessed at http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets
.
V. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (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.
Title: Requests for Inspection under the Inspection by Accredited
Persons Program
Description: Section 201 of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amends section
704 of the Federal Food, Drug, and Cosmetic Act (the act) by adding
paragraph (g). This amendment authorizes FDA to establish a voluntary
third party inspection program applicable to manufacturers of class II
or class III medical devices who meet certain eligibility criteria.
Under this new Inspection by Accredited Persons Program (AP program),
such manufacturers may elect to have third parties that have been
accredited by FDA (accredited person or AP) conduct some of their
inspections instead of FDA.
The AP program applies to manufacturers who currently market their
medical devices in the United States and who also market or plan to
market their devices in foreign countries. Such manufacturers may need
current inspections of their establishments to operate in global
commerce.
The applicant must submit the following information in support of a
request for approval to use an AP:
1. Information that shows that the applicant ``manufactures,
prepares, propagates, compounds, or processes'' class II or class III
medical devices.
2. Information that shows that the applicant markets at least one
of the devices in the United States.
3. Information that shows that the applicant markets or intends to
market at least one of the devices in one or more foreign countries and
one or both of the following two conditions are met as follows:
a. One of the foreign countries certifies, accredits, or otherwise
recognizes the AP the applicant has selected as a person authorized to
conduct inspections of device establishments, or
b. A statement that the law of a country where the applicant
markets or intends to market the device recognizes an inspection by the
FDA or by the AP.
4. Information that shows that the applicant's most recent
inspection performed by FDA, or by an AP under this program, was
classified by FDA as either ``No Action Indicated (NAI)'' or
``Voluntary Action Indicated (VAI)''; and
5. A notice to FDA requesting clearance (approval) to use an AP,
and identifying the AP the applicant selected.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
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100 1 100 15 1,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
There are approximately 8,000 foreign and 10,000 domestic
manufacturers of medical devices. Approximately 5,000 of these firms
only manufacture class I devices and are, therefore, not eligible for
the AP program. In addition, 40 percent of the domestic firms do not
export devices and therefore are not eligible for the AP program. Also
10 to 15 percent of the firms are not eligible due to the results of
their previous inspection. FDA estimates that there are 4,000 domestic
manufacturers and 4,000 foreign manufacturers that are eligible for
inclusion in the AP program. Based on informal communications with
industry, FDA estimates that approximately 100 of these manufacturers
may apply to use an AP in any given year.
Dated: May 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12683 Filed 6-1-04; 11:45 am]
BILLING CODE 4160-01-S