Immediate third-party review sought by device industry in Kassebaum FDA reform bill.
This article was originally published in The Gray Sheet
Executive Summary
THIRD-PARTY DEVICE REVIEW OPTION IMMEDIATELY UPON ENACTMENT of FDA reform legislation is being sought by device industry lobbyists for inclusion in Sen. Nancy Kassebaum's (R-Kan.) upcoming bill. Instead of delaying for several years the requirement that FDA farm out premarket device reviews to outside groups -- as proposed in draft legislation released by Kassebaum the week of Oct. 30 ("The Gray Sheet" Nov. 6, p. 3)-- industry reps say use of third parties should be imposed immediately.
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