COVID-19: FDA Webinar Highlights Developer Challenges
A recent US FDA webinar offered insights on the technical challenges developers face in trying to get COVID-19 diagnostics to US patients.
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Medtech Insight is tracking the IVD companies manufacturing tests for SARS-CoV-2, the coronavirus that causes COVID-19.
The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.
Agency won’t require manufacturers to submit class I devices to the database for an extra 75 days, and doesn't plan to enforce GUDID regulations against consumer health products.