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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › FDA Draft Guidance Aims to Make Dual CLIA Waiver, 510(k) Process Less Burdensome

FDA Draft Guidance Aims to Make Dual CLIA Waiver, 510(k) Process Less Burdensome

Nov 29, 2017
|
staff reporter

NEW YORK (360Dx) – The US Food and Drug Administration has released a new draft guidance document on applying for Clinical Laboratory Improvement Amendment waivers, including recommendations for making the dual CLIA waiver and 510(k) clearance pathway less burdensome.

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