DEVICE MANUFACTURERS COULD ENTER CONTRACTS WITH THIRD PARTIES FOR REVIEWS OF ALL DEVICE TYPES UNDER COATS AMENDMENT TO KASSEBAUM FDA REFORM BILL
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers would have the option to contract directly with accredited third-party organizations for reviews of 510(k)s and premarket approval applications under the amended version of Sen. Nancy Kassebaum's (R-Kan.) FDA reform bill (S 1477) reported out of the Senate Labor and Human Resources Committee March 28.