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.


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