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# Draft Guide on Dual 510(k) and CLIA Waiver
- URL: https://www.fdaweb.com/draft-guide-on-dual-510-k-and-clia-waiver-2/
- Published: 2018-11-29T12:00:00.000Z
- Updated: 2026-09-15T00:47:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142919

*Federal Register* notice: FDA has made available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” The document describes study designs for generating data that support both 510(k) clearance and CLIA waiver. FDA says that using the dual use pathway is optional; however, it believes that this would be the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver in addition to 510(k) clearance for new in vitro diagnostic devices. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-29/pdf/2018-25960.pdf?ref=fdaweb.com).