FDA Guidance on PGx Tests for Heritable Markers Does Not Say When 510(k), PMA Needed | GenomeWeb
A recently released guidance to industry and US Food and Drug Administration staff, called “Pharmacogenetic Tests and Genetic Tests for Heritable Markers,” is not explicit enough in outlining when diagnostic companies will need to apply for premarket approval and when a 510(k) clearance will be sufficient, according to a lawyer representing the interests of diagnostic companies, patient groups, and investors.

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