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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

Manufacturers will no longer need to submit 510(k)s for 10 unclassified device types that range from speech training aids to temperature discrimination tests.

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.


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