[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