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# Dual 510(k) CLIA Waiver Guidance
- URL: https://www.fdaweb.com/dual-510-k-clia-waiver-guidance/
- Published: 2017-11-28T12:00:00.000Z
- Updated: 2026-09-14T23:03:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140213

FDA has issued a draft guidance, *Recommendations for Dual 510(k) and CLIA Waiver by Application Studies*, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM586502.pdf?ref=fdaweb.com) says use of the guidance is expected to reduce study-related costs and provide time savings for manufacturers of certain Class 1 and 2 IVD devices intended for CLIA waived settings.

The guidance describes study designs for generating study 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; however, FDA believes this pathway 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,” it says