Cures Draft Includes 510(k)s In Priority Review, Accelerated Approval Provisions

House lawmakers took up a medical device industry suggestion by extending the availability of priority review for breakthrough devices to 510(k)s in their 21st Century Cures draft bill, as well as establishing an accelerated approval pathway for these devices. This goes further than a draft guidance FDA released in April that outlined an expedited access plan for premarket approval (PMA) devices and which drew criticism from patient and consumer advocates who said device approval standards were already too low. The...