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See today's BioWorld MedTech
Home » FDA wraps up CLIA-related guidances for 510(k) diagnostics
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FDA wraps up CLIA-related guidances for 510(k) diagnostics

Feb. 27, 2020
By Mark McCarty
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
BioWorld MedTech Regulatory 510(k) FDA

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