[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Notices]
[Pages 25752-25753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10178]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0228] (formerly Docket No. 00D-1401)
Guidance for Industry and Food and Drug Administration Staff;
Administrative Procedures for CLIA Categorization; 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 ``Administrative Procedures for
CLIA Categorization.'' The guidance describes FDA's current practices
concerning the administrative aspects of categorizing commercially
available in vitro diagnostic tests under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA). The guidance discusses what
manufacturers should submit to help expedite CLIA categorization by
FDA.
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 of the guidance
document entitled ``Administrative Procedures for CLIA Categorization''
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 the office in processing
your request, or fax your request to 240-276-3151. 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://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0491, ext. 117.
SUPPLEMENTARY INFORMATION:
I. Background
On February 28, 1992, the Department of Health and Human Services
published the final laboratory standards regulations (57 FR 7002)
implementing CLIA (42 U.S.C. 263a). The implementing regulations are
codified at 42 CFR part 493. CLIA regulates laboratory testing and
requires that clinical laboratories obtain a certificate
[[Page 25753]]
before accepting materials derived from the human body for the purpose
of providing information for the diagnosis, prevention, or treatment of
any disease or the impairment of, or assessment of the health of human
beings. The type of CLIA certificate a laboratory obtains depends upon
the complexity of the tests it performs. CLIA regulations describe
three levels of test complexity: Waived tests, moderate complexity
tests, and high complexity tests.
On January 31, 2000, the responsibility for categorization of
commercially marketed in vitro diagnostic (IVD) tests was transferred
from the Centers for Disease Control and Prevention to FDA (64 FR
73561, December 30, 1999). This allows IVD test manufacturers to submit
premarket (510(k)) notifications or applications and requests for
complexity categorization under CLIA to one agency. This notice
announces the availability of a guidance document that describes the
general administrative procedures FDA uses to assign a device's
complexity category under CLIA.
The draft of this guidance was issued August 14, 2000, and the
comment period closed on November 13, 2000. FDA did not receive any
comments concerning the ``Draft Guidance on Administrative Procedures
for CLIA Categorization.'' In preparing the final guidance, however,
FDA needed to obtain an approval for a new collection of information
from the Office of Management and Budget (OMB). We obtained this
approval (see section IV. Paperwork Reduction Act of 1995) and are now
issuing the final guidance. Updates added to the guidance include a
revised background section and procedures for CLIA categorization for
510(k) submissions submitted electronically. The guidance also notes
that manufacturers who wish to request CLIA waiver for a device (other
than those devices already waived under 42 CFR 493.15), should refer to
the guidance entitled ``Guidance for Industry and FDA Staff:
Recommendations for Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic
Devices,'' issued in January 2008.
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 administrative procedures for CLIA
categorization. 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
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Administrative Procedures for CLIA
Categorization,'' you may either send an e-mail request to
[email protected] to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1143 to identify the guidance you are requesting.
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://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 at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520). The collections of information in this guidance were
approved under OMB control number 0910-0607.
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: April 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10178 Filed 5-6-08; 8:45 am]
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