US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019

Danelle Hidano; Sanket S Dhruva; Rita F Redberg

doi:10.1001/jamainternmed.2022.0184

US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019

JAMA Intern Med. 2022 May 1;182(5):556-558. doi: 10.1001/jamainternmed.2022.0184.

Authors

Danelle Hidano¹, Sanket S Dhruva², Rita F Redberg²

Affiliations

¹ University of Washington, Seattle.
² Division of Cardiology, Department of Medicine, and Philip R. Lee Institute of Health Policy Studies, University of California, San Francisco.

Abstract

This qualitative study assesses the availability and strength of evidence of postapproval studies for high-risk cardiovascular devices subsequent to the 21st Century Cures Act.

MeSH terms

Drug Approval*
Humans
Product Surveillance, Postmarketing*
United States
United States Food and Drug Administration