The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?

Affiliations

¹ Yale University School of Medicine, New Haven, Connecticut.
² Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
³ Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut4Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.

Vinay K Rathi et al. JAMA Cardiol. 2016.

. 2016 May 1;1(2):117-8.

doi: 10.1001/jamacardio.2016.0002.

¹ Yale University School of Medicine, New Haven, Connecticut.
² Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
³ Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut4Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.

No abstract available

Comment in

The US Food and Drug Administration Premarket Approval Process and the 515 Program Initiative: View From a Panel Chair.
Page RL. Page RL. JAMA Cardiol. 2016 May 1;1(2):119-20. doi: 10.1001/jamacardio.2016.0007. JAMA Cardiol. 2016. PMID: 27437880 No abstract available.