Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020

James L Johnston; Sanket S Dhruva; Joseph S Ross; Vinay K Rathi

doi:10.1001/jamainternmed.2021.3042

Assessment of FDA Approval for New High-risk Therapeutic Devices Not Meeting Pivotal Study Primary End Points, 2016-2020

JAMA Intern Med. 2021 Oct 1;181(10):1409-1412. doi: 10.1001/jamainternmed.2021.3042.

Authors

James L Johnston¹, Sanket S Dhruva^{2

3}, Joseph S Ross^{4

5

6}, Vinay K Rathi⁷

Affiliations

¹ Yale School of Medicine, Yale University, New Haven, Connecticut.
² San Francisco VA Medical Center, San Francisco, California.
³ Department of Medicine, UCSF School of Medicine, University of California, San Francisco.
⁴ Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, New Haven, Connecticut.
⁵ Department of Health Policy and Management, Yale School of Public Health, Yale University, New Haven, Connecticut.
⁶ Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, Yale University, New Haven, Connecticut.
⁷ Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston.

Abstract

This cross-sectional study explores the frequency of, and rationale for, US Food and Drug Administration approval of high-risk therapeutic medical devices not meeting pivotal study primary end points from 2016 through 2020.

Publication types

Comment

MeSH terms

Device Approval*
Humans
United States
United States Food and Drug Administration

Grant support

UL1 TR001863/TR/NCATS NIH HHS/United States