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# Dual 510(k)/CLIA Waiver Guide
- URL: https://www.fdaweb.com/dual-510-k-clia-waiver-guide/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146181

*Federal Register* notice: FDA has made available a final guidance entitled “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.” The document describes study designs for generating data that may support both 510(k) clearance and a Clinical Laboratory Improvement Amendments waiver. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-26/pdf/2020-03859.pdf?ref=fdaweb.com).