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Latest 510(k) Exemption Notice Includes 'Firm-Based' DTC Genetic Screening Policy

 
• By David Filmore

US FDA finalized 510(k) exemptions for five device types, including a novel exemption approach to consumer genetic predisposition tests.

510(k)s exempted codes

[Editor's note: This article was updated June 14 to mention Sciex's 2017 de novo classification for its mass spectrometry vitamin D assay as the original proposal to exempt that device category.]

US FDA finalized 510(k) exemptions for five class II device categories June 1, including a novel sponsor-by-sponsor exemption policy for direct-to-consumer genetic health risk assessment systems.

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