Review times and adverse events for cardiovascular devices

Nat Biomed Eng. 2017 Jan;1(1):0013. doi: 10.1038/s41551-016-0013. Epub 2017 Jan 10.

Ariel Dora Stern^{1

2}, Daniel B Kramer^{3

4

5}, Melissa Ouellet¹, Aaron S Kesselheim^{3

4}

¹ Harvard Business School, Soldiers Field Road, Boston, Massachusetts 02163, USA.
² Ariadne Labs at Brigham and Women's Hospital and the Harvard T. H. Chan School of Public Health, Boston, Massachusetts 02215, USA.
³ Harvard Medical School, 25 Shattuck Street, Boston, Massachusetts 02115, USA.
⁴ Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115, USA.
⁵ Richard and Susan Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA.

Abstract

Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.