Dual 510(k), CLIA Waiver Application Guidance

FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application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 describes study designs for generating data that support both 510(k) clearance and CLIA waiver.

The agency says that while using this pathway is optional, it believes that the pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver in addition to 510(k) clearance for new in vitro diagnostic (IVD) devices. “FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA-waived settings, which will better serve patients and providers,” the guidance says.

The document covers Introduction, Background, Scope, Process and Content of a Dual Submission, and General Study Design Considerations.