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Recommendations for Dual 510(k) and CLIA Waiver by Application Studies Guidance for Industry and Food and Drug Administration Staff February 2020

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway. It describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new In Vitro Diagnostic (IVD) tests. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD tests to CLIA-waived settings, which will better serve patients and providers.

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

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:

Dockets Management
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-5625.

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