FDA Issues Draft Guidance for Dual 510(k), CLIA Waiver Applications

December 4, 2018

The FDA released draft recommendations for device sponsors on study designs to generate data to support a dual application for a 510(k) clearance and a waiver under the Clinical Laboratory Improvement Amendments (CLIA).

The agency believes the dual approach is in many instances the least burdensome and fastest way for manufacturers to get a CLIA waiver and 510(k) clearance for new in vitro diagnostic devices.

The draft guidance recommends that applicants use the MDUFA IV commitment letter to discuss planned designs for studies that support both the 510(k) clearance and the CLIA waiver.

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