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GUIDANCE DOCUMENT

Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff November 2018

Draft

Not for implementation. Contains non-binding recommendations.

Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

Docket Number:
FDA-2017-D-5570
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this draft guidance to implement section 3057 of the 21st Century Cures Act [P.L. 114-255], which requires FDA to revise “Section V. Demonstrating Insignificant Risk of an Erroneous Result — Accuracy” of the guidance Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices (“2008 CLIA Waiver Guidance”) that was issued on January 30, 2008. This draft guidance represents FDA’s current thinking regarding “the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.” The 2008 CLIA Waiver Guidance remains in effect, in its current form, until this draft guidance is finalized, at which time the updates in section III of this draft guidance will supersede the recommendations in section V of the 2008 CLIA Waiver Guidance.

FDA will incorporate the final version of this draft guidance into “Section V. Demonstrating Insignificant Risk of an Erroneous Result — Accuracy” of the 2008 CLIA Waiver Guidance. The remainder of the 2008 CLIA Waiver Guidance, with exception of technical edits for consistency with the newly amended section V, will 89 not be substantively changed and will remain in effect.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5570.