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# Two Device Guides on CLIA Waivers
- URL: https://www.fdaweb.com/two-device-guides-on-clia-waivers/
- Published: 2020-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:04:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146164

FDA has issued two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments (CLIA) waivers for certain products. The [first guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-510k-and-clia-waiver-application-studies?ref=fdaweb.com), *Recommendations for Dual 510(k)* and CLIA Waiver by Application Studies, is intended to assist manufacturers in using the agency’s dual 510(k) and CLIA waiver by application pathway. It describes study designs for generating data that may support both510(k) clearance and a CLIA waiver. FDA believes this pathway is the least burdensome and fastest approach for manufacturers to obtain both a CLIA waiver and 510(k) clearance for new in vitro diagnostic (IVD) tests.

  
The [second guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications?ref=fdaweb.com), *Recommendations for Clinical* Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices, describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory waiver criteria. The document includes FDA’s revised thinking on the “appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.” It also provides additional approaches for demonstrating that a test meets the waiver criteria.