CLIA Admin Guidance

Guidance for Industry and FDA
Staff
Administrative Procedures
for CLIA Categorization
Document issued on: May 7, 2008
The draft of this document was issued on August 14, 2000.
OMB control number: 0910-0607
Expiration Date: 09/30/2010

See additional PRA statement in Section 4 of this guidance.
For questions regarding this document, contact Carol Benson at 240-276-0396 or by e-mail at
[email protected].

U.S. Department of Health and Human Services
Food and Drug
Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety

Contains Nonbinding Recommendations

Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane,
Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be
submitted to http://www.regulations.gov. When submitting comments, please reference the
docket number FDA-2008-D-0228. Comments may not be acted upon by the Agency until the
document is next revised or updated.

Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/oivd/guidance/1143.pdf. You may also send an e-mail request to
[email protected] to receive an electronic copy of the guidance 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.

Contains Nonbinding Recommendations

Table of Contents
1.
2.
3.
4.

Introduction....................................................................................................................... 1
The Least Burdensome Approach ..................................................................................... 2
Procedures for Determination of CLIA Categorization.................................................... 2
CLIA Waiver Protocols and Applications ........................................................................ 4
Paperwork Reduction Act of 1995…..…………………………………………………...4

Contains Nonbinding Recommendations

Guidance for Industry and FDA Staff
Administrative Procedures
for CLIA Categorization
This guidance represents the Food and Drug Administration's (FDA's) current thinking
on this topic. It does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternative approach if the approach
satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.

1.

Introduction

On February 28, 1992, the Department of Health and Human Services (DHHS) published
laboratory standards regulations (57 FR 7002) implementing the Clinical Laboratory
Improvement Amendments of 1988 (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 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 the following three levels of test complexity: waived tests,
moderate complexity tests, and high complexity tests. 42 CFR 493.5(a).
On January 31, 2000, the responsibility for categorization of commercially available in vitro
diagnostic (IVD) tests was transferred from the Centers for Disease Control and Prevention
(CDC) to the Food and Drug Administration (FDA). 1 This allows IVD manufacturers to
submit premarket notifications or applications for tests and requests for complexity
categorization of these tests under CLIA to one agency.

1

64 FR 73561, December 30, 1999. See also the delegation to FDA to categorize
commercially available in vitro diagnostic tests and perform associated functions (69 FR
22849, April 27, 2004).
1

Contains Nonbinding Recommendations
This guidance document describes the general administrative procedures FDA will use to
categorize tests under CLIA. This guidance does not specifically address CLIA waiver
applications. For more information on CLIA waiver applications, you may 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.” 2
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.

The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device
regulation. This guidance reflects our careful review of the relevant scientific and legal
requirements and what we believe is the least burdensome way for you to comply with those
requirements. However, if you believe that an alternative approach would be less
burdensome, please contact us so we can consider your point of view. You may send your
written comments to the contact person listed in the preface to this guidance or to the CDRH
Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to
contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.

2.

Procedures for Determination of CLIA
Categorization

CLIA categorization of IVD tests is determined by FDA at the time of review of a premarket
notification submission (510(k)) or premarket approval application (PMA) under the Federal
Food, Drug, and Cosmetic Act. In cases where a 510(k) or PMA is not needed but CLIA
categorization is still appropriate, manufacturers should submit a request for CLIA
categorization, including a copy of the test package insert with test instructions, to FDA (see
the table below for examples).
For moderate and high complexity tests, FDA determines test complexity by reviewing the
package insert test instructions in the premarket submission, using the criteria listed in 42
CFR 493.17. The determination for waived tests is based on the list of tests specified as
waived by regulation under 42 CFR 493.15. Manufacturers requesting CLIA waiver for tests
not waived by this regulation should submit a CLIA waiver application (see Section 3,
below). These applications are typically submitted after the test is cleared or approved by
FDA.
2

http://www.fda.gov/cdrh/oivd/guidance/1171.html.
2

Contains Nonbinding Recommendations

In order to expedite CLIA categorization by FDA, manufacturers should submit the material
described in the following table. You should address the information to CDRH's Document
Mail Center (DMC), HFZ-401, 9200 Corporate Blvd., Rockville MD 20850.
In the following situations:
510(k) (Traditional or abbreviated) 3

The sponsor should provide:
A copy of the package insert identified as "For
CLIA categorization." The package insert that
the manufacturer provides in the duplicate copy
of the 510(k) can be used for this purpose.

Electronic 510(k) or PMA submissions

The electronic version of the package insert can
be used for CLIA categorization. No additional
information needed.

Special 510(k) 4

A package insert identified as "For CLIA
categorization." The package insert that the
manufacturer provides in the duplicate copy of
the 510(k) can be used for this purpose.
(Note: If the device has already been
categorized, it may not need re-categorization
when the Special 510(k) is cleared. FDA
evaluates each submission to determine if CLIA
categorization is needed.)

A test that is exempt from 510(k) review

A package insert identified as: “For CLIA
categorization only – 510(k) exempt device,”
and the classification regulation number,
classification, and product code.

A test system that falls under the
Replacement Reagent Policy. (See
http://www.fda.gov/cdrh/oivd/guidance/950.
pdf for guidance on OIVD’s Replacement
Reagent and Instrument Family Policy.)
Original PMA or PMA Supplement

A package insert identified as: “For CLIA
categorization only” and a reference to the
original 510(k), including the classification
regulation numbers, classification, and product
codes for the test and instrument.
A copy of the package insert identified as "For
CLIA categorization." The package insert that
the manufacturer provides in the duplicate copy
of the submission can be used for this purpose.

3

See guidance entitled “Format for Traditional and Abbreviated 510(k)s” at
http://www.fda.gov/cdrh/ode/guidance/1567.pdf.
4
See Device Advice page entitled “How To Prepare a Special 510(k)” at
http://www.fda.gov/cdrh/devadvice/3144.html.
3

Contains Nonbinding Recommendations
Additionally, FDA recommends that where the name of an approved or cleared device
changes, or the name of the manufacturer or distributor changes, the manufacturer should
submit the updated label to FDA so that its record of categorized tests is accurate.
FDA will notify manufacturers of the assigned complexity through written correspondence.
Categorization will be effective as of the date of the written notification to the manufacturer
(see 42 CFR 493.17(c)(1)(ii)). A searchable database of CLIA categorizations for IVD
devices, which is updated periodically, is available at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm.

3.

CLIA Waiver Protocols and Applications

We recommend that a manufacturer who wishes to request CLIA waiver for a device (other
than those devices already waived by 42 CFR 493.15), 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.” Manufacturers have the option to submit their planned protocols
or study designs to support CLIA waiver in order to obtain feedback from FDA prior to
conducting the study. These planned protocols or study designs are logged in by the
document mail center as “Pre-IDEs.” See the FDA website for more information on the PreIDE process: http://www.fda.gov/cdrh/devadvice/ide/approval.shtml. Pre-IDEs for CLIA
waiver should include a reference to the original 510(k) or PMA number, 2 copies of the
protocol/study design, and an electronic version if available.

4. 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 time required to complete this information collection is estimated to average 900 hours
per response, including the time to review instructions, search existing data sources, gather
the data needed, and complete and review the information collection. Send comments
regarding this burden estimate or suggestions for reducing this burden to:
Carol Benson,
Center for Devices and Radiological Health (HFZ-440),
Food and Drug Administration,
2098 Gaither Road,
Rockville, MD 20850.
This guidance also refers to previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR Part 801 have been approved under
OMB control number 0910-0485 and the collections of information in 21 CFR Part 807,
subpart E have been approved under OMB control number 0910-0120.

4

Contains Nonbinding Recommendations

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The OMB
control number for this information collection is 0910-0607 (expires 09/30/2010).

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