[Federal Register Volume 69, Number 107 (Thursday, June 3, 2004)]
[Notices]
[Pages 31397-31398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12683]


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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Draft Guidance for Industry, Food and Drug Administration Staff, 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availability of the draft guidance entitled ``Requests for Inspection 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 This draft guidance 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DATES:  Submit written or electronic comments on this draft guidance by 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