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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/
- Published: 2017-11-30T12:00:00.000Z
- Updated: 2026-09-14T23:04:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140239

*Federal Register* notice: FDA has made available a draft guidance entitled “Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.” It describes study designs for generating data that supports both 510(k) clearance and CLIA-waived categorization. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional, but the agency says it is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA-waived categorization 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-2017-11-29/pdf/2017-25774.pdf?ref=fdaweb.com).