[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Notices]               
[Page 54562-54563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se05-46]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0251]

 
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 guidance entitled ``Requests for Inspection by an 
Accredited Person under the Inspection by Accredited Persons Program 
Authorized by Section 201 of the Medical Device User Fee and 
Modernization Act of 2002.'' The Medical Device User Fee and 
Modernization Act of 2002 authorizes FDA to establish a voluntary 
inspection program under which manufacturers of class II or class III 
devices who meet certain eligibility criteria as defined by the statute 
can elect to have FDA-accredited third parties conduct some of their 
establishment inspections instead of FDA. This guidance document 
describes the establishment eligibility criteria and the process for 
establishments to follow when requesting FDA's approval to have an 
accredited person (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 guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Requests for Inspection by 
an Accredited Person 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 one self-addressed adhesive label 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 concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify 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 Rd., Rockville, MD

[[Page 54563]]

20850, 240-276-0106.
    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

    On October 26, 2002, the Medical Device User Fee and Modernization 
Act of 2002 (MDUFMA) (Public Law 107-250) was signed into law. Section 
201 of MDUFMA amends the Federal Food, Drug, and Cosmetic Act (the act) 
by adding new provisions authorizing FDA to establish a voluntary 
inspection program under which eligible manufacturers of class II or 
class III devices can elect to have FDA-accredited third parties 
conduct some of their establishment inspections instead of FDA. Certain 
technical corrections were subsequently made to these provisions by the 
Medical Devices Technical Corrections Act (MDTCA) (Public Law 108-214), 
which was enacted on April 1, 2004. FDA announced in the Federal 
Register of June 3, 2004 (69 FR 31397), the availability of a draft 
guidance document 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,'' and invited interested persons to comment by September 1, 2004.
    One person submitted a comment in response to the draft guidance. 
The comment suggested, among other things, that partial inspections 
during a 2-year period should be permitted without the need for 
establishments to have to reapply to participate in the AP Program 
after each partial inspection. The comment further suggested that the 
guidance be revised to explicitly state that complete inspections 
conducted by APs under the new program which result in either a ``No 
Action Indicated'' or ``Voluntary Action Indicated'' classification can 
satisfy FDA's biennial establishment inspection requirement under 
section 510(h) of the act (21 U.S.C. 360(h)). The agency carefully 
considered the comment while finalizing the guidance and has revised 
the document accordingly.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on implementation of a new program that 
allows third-party inspections of eligible device establishments as 
authorized by section 201 of MDUFMA (as amended by MDTCA). 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

    To receive ``Requests for Inspection by an Accredited Person under 
the Inspection by Accredited Persons Program Authorized by Section 201 
of the Medical Device User Fee and Modernization Act of 2002'' by fax, 
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. The Center for Devices and Radiological 
Health (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 approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
 A search capability for all CDRH guidance documents is available 

at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 

available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.


IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing the agency request or requirement that members of the public 
submit reports, keep records, or provide information to a third party. 
The provisions addressed in the guidance have been approved by OMB 
under OMB control number 0910-0569. This approval expires on August 31, 
2008. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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.

    Dated: September 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18364 Filed 9-14-05; 8:45 am]

BILLING CODE 4160-01-S