[Federal Register: November 6, 2003 (Volume 68, Number 215)]
[Notices]               
[Page 62811-62812]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no03-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
List of Accredited Persons; Inspection by Accredited Persons 
Program Under the Medical Device User Fee and Modernization Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the list of persons who are accredited under certain 
circumstances to inspect eligible manufacturers of class II and class 
III devices in lieu of an FDA inspection. This list provides the 
identity of each accredited person and the particular activities for 
which the person is accredited. FDA is taking this action to implement 
provisions of the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA).

ADDRESSES: This list is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ap-inspection/.
 Submit a written request for copies of 
the List of Accredited Persons to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health (CDRH), 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 list of accredited persons.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 124.

SUPPLEMENTARY INFORMATION:

I. Background

    MDUFMA (Public Law 107-250) was signed into law on October 26, 
2002. Section 201 of MDUFMA adds a paragraph ``g'' to section 704 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), 
directing FDA to accredit third parties (accredited persons or APs) to 
conduct inspections of eligible manufacturers of class II or class III 
devices. Participation in the program is voluntary. Manufacturers may 
continue to have FDA perform inspections or, if eligible, they may 
utilize an accredited person. The new law requires FDA, within 180 days 
from the date MDUFMA was signed into law, to publish in the Federal 
Register, criteria to accredit or deny accreditation to persons who 
request to perform these inspections (section 704(g)(2) of the act). 
FDA published the criteria it used to accredit persons for the purpose 
of conducting inspections of eligible manufacturers of class II and 
class III devices in the Federal Register of April 28, 2003 (68 FR 
22400).
    The new law also directed FDA to accredit up to 15 third parties to 
conduct inspections by no later than 1 year after MDUFMA was enacted 
and to publish on the FDA Internet site a list of persons who are 
accredited (21 U.S.C. 374(g) (4)). Under the new provision, FDA must 
update this list to ensure that the identity of each accredited person, 
and the particular activities for which the person is accredited, is 
known to the public. Under this new provision, FDA must also update the 
list no later than 1 month after the accreditation of a person, or the 
suspension or withdrawal of accreditation, or the modification of the 
particular activities for which the person is accredited.
    FDA is currently developing guidance to help establishments 
determine whether they are qualified to participate in the third party 
inspection program. Because all accredited persons will have to 
complete training before conducting independent inspections under the 
new program, these APs will not be available to companies for several 
months. FDA plans to make the guidance available before the APs have 
completed the training. In the meantime, any company that is interested 
in participating in the third party inspection program may contact the 
contact person (see FOR FURTHER INFORMATION CONTACT) to get more 
information about eligibility.

II. Electronic Access

    Persons interested in obtaining a copy of the list of accredited 
persons may also do so by using the Internet. 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 The list of accredited persons is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ap-inspection/.


[[Page 62812]]

    To receive the list of accredited persons 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 (1500) 
followed by the pound sign (). Follow the remaining voice 
prompts to complete your request.

    Dated: October 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27879 Filed 11-5-03; 8:45 am]

BILLING CODE 4160-01-S