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Physicians Lack Incentives For FDA Postmarket Study Participation, But Progress ‘Adequate,’ GAO Finds

This article was originally published in The Gray Sheet

Executive Summary

Participation in postmarket device studies can be low because physicians and patients lack incentives to sign up, but in general, progress on postapproval studies for class III products is “adequate.” But most postmarket surveillance studies, ordered under Section 522, are listed by FDA as inactive, a GAO report ordered by Rep. DeLauro finds.

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