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Home » FDA Releases Guidances on Dual 510(k)-CLIA Waiver Submissions
FDA Releases Guidances on Dual 510(k)-CLIA Waiver Submissions
The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation.