[Federal Register Volume 73, Number 20 (Wednesday, January 30, 2008)]
[Notices]
[Pages 5574-5575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0031] (formerly Docket No. 2001D-0044)


Guidance for Industry and Food and Drug Administration Staff; 
Clinical Laboratory Improvement Amendments of 1988: Recommendations for 
Clinical Laboratory Improvement Amendments of 1988: Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices; 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 ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices.'' FDA is issuing this 
guidance to recommend approaches for determining whether a laboratory 
test may be performed by laboratories with a certificate of waiver 
under CLIA.

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 ``Recommendations for Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices'' 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 
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, 240-276-0396.

SUPPLEMENTARY INFORMATION:

I. Background

    CLIA requires that clinical laboratories obtain a certificate from 
the Secretary of Health and Human Services (the Secretary) before 
accepting materials derived from the human body for laboratory tests 
(42 U.S.C. 263(b)). Laboratories that perform only tests that are 
``simple'' and that have an ``insignificant risk of an erroneous 
result'' may obtain a certificate of waiver (42 U.S.C. 263a(c)(2)). The 
Secretary has delegated to FDA the authority to determine under CLIA 
whether particular tests (waived tests) are ``simple'' and have ``an 
insignificant risk of an erroneous result'' (69 FR 22849, April 27, 
2004). This guidance describes recommendations for device manufacturers 
seeking to submit information (CLIA waiver application) to FDA to 
support a determination that a cleared or approved in vitro diagnostic 
(IVD) device meets this CLIA waiver standard.
    In the guidance document, FDA recommends an approach for 
manufacturers to demonstrate in a CLIA waiver application that a device 
is simple and has an insignificant risk of erroneous result as required 
under CLIA (42 U.S.C. 263a). FDA based the recommendations in the 
guidance

[[Page 5575]]

document on interpretation of the law, experience with CLIA complexity 
determinations, and comments and information from stakeholders.
    The draft of this guidance was issued September 7, 2005 (70 FR 
53231). FDA received and considered approximately 40 sets of comments 
on the draft guidance document. After taking the comments into 
consideration, FDA has updated the document to provide clarifications 
as needed. The guidance has also been revised to allow for additional 
supplementation of the actual patient specimens in the clinical study 
with alternative samples, preferably banked patient samples. The 
revised guidance recommends that, when neither patient specimens nor 
banked samples are available, it may be acceptable to supplement with 
other types of prepared samples, e.g., spiked, or diluted samples that 
mimic patient samples in terms of analyte and matrix. The revised 
guidance specifies that up to a total of one third of the clinical 
study samples may be supplemented with these types of alternative 
samples. The revised guidance also provides more flexibility in 
selecting the comparator method as well as more consistency in terms of 
the criteria for accuracy for waived tests as compared with moderate 
and high complexity tests.

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 reporting results from studies evaluating 
diagnostic tests. 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 ``Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices,'' 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 1171 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.fda.gov/ohrms/dockets/default.htm.

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 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0598.

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 Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: January 22, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1557 Filed 1-29-08; 8:45 am]
BILLING CODE 4160-01-S