[Federal Register Volume 73, Number 89 (Wednesday, May 7, 2008)]
[Pages 25752-25753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10178]



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.


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 

DATES:  Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 

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.


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]