[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5574-5575]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja08-89]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html Guidance documents are also available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
ult.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]
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