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Comment
. 2021 Oct 1;181(10):1409-1412.
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

James L Johnston  1 , Sanket S Dhruva  2   3 , Joseph S Ross  4   5   6 , Vinay K Rathi  7
Affiliations
Comment

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

James L Johnston et al. JAMA Intern Med. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Mr Johnston reported receiving grants from the US Food and Drug Administration (FDA) through the Yale University–Mayo Clinic Center of Excellence in Regulatory Science and Innovation program. Dr Dhruva reported receiving research support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (K12HL138046); the FDA; the Medical Device Innovation Consortium as part of National Evaluation System for Health Technology Coordinating Center; Arnold Ventures; and the Greenwall Foundation. Dr Ross reported receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; the FDA to establish the Yale University–Mayo Clinic Center of Excellence in Regulatory Science and Innovation program (U01FD005938); the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology Coordinating Center; the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung, and Blood Institute of the National Institutes of Health (R01HS025164 and R01HL144644); and Arnold Ventures to establish the Good Pharma Scorecard at Bioethics International and the Collaboration for Research Integrity and Transparency at Yale. No other disclosures were reported.

Comment on

References

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