Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices

JAMA Intern Med. 2020 May 1;180(5):801-803. doi: 10.1001/jamainternmed.2020.0297.

Authors

Caroline Ong¹, Vy K Ly², Rita F Redberg^{3

4}

Affiliations

¹ Division of Cardiology, New York University, New York.
² UCSF School of Medicine, University of California, San Francisco.
³ Division of Cardiology, UCSF School of Medicine, University of California, San Francisco.
⁴ Editor.

Abstract

This study compares US Food and Drug Administration premarket approval review times for priority vs standard review for high-risk devices.

Publication types

Comparative Study

MeSH terms

Databases, Factual
Device Approval*
Equipment and Supplies*
Humans
Time Factors
United States
United States Food and Drug Administration