Latest 510(k) Exemption Notice Includes 'Firm-Based' DTC Genetic Screening Policy
Executive Summary
US FDA finalized 510(k) exemptions for five device types, including a novel exemption approach to consumer genetic predisposition tests.
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US FDA Drops 510(k) Requirement On 10 Device Types
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US FDA Implements 'Firm-Based' Regulatory Approach To DTC Genetic Health Risk Tests
Formalizing an approach applied to oversight of 23AndMe's direct-to-consumer genetic health risk tests, US FDA Nov. 6 said it plans to allow DTC testing services to be exempted from pre-market review after each individual maker of such an offering comes to the agency for a one-time review to ensure it meets FDA requirements.
23andMe Opens Up FDA Pathway For DTC Genetic Predisposition Tests
23andMe has made it full circle with at least 10 direct-to-consumer genetic predisposition tests gaining FDA go-ahead for testing services to provide information on an individual's risk for developing Alzheimer's, Parkinson's, and celiac disease, among others. The de novo classification comes three-and-half years after the firm's DTC genetic testing service was forced off the market by FDA, and two years after it was able to relaunch carrier-screening test services.