Monday, February 2, 2015

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

Cures Draft Includes 510(k)s In Priority Review, Accelerated Approval Provisions-insidehealthpolicy: 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.