> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Too Few High-Risk CV Device Post-Approval Studies
- URL: https://www.fdaweb.com/too-few-high-risk-cv-device-post-approval-studies/
- Published: 2022-03-17T12:00:00.000Z
- Updated: 2026-09-14T17:36:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151394

University of California San Francisco researchers say that since the implementation of the 21st Century Cures Act, which directed FDA to consider the role of post-market information in determining the least burdensome means for approval, there has been no significant increase in the frequency of FDA post-approval study mandates for the highest risk cardiovascular devices, despite increased reliance on such data for some devices. Writing in *JAMA Internal Medicine* (subscription or purchase required), the researchers [say](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790061?ref=fdaweb.com) post-approval studies were limited by delays, revisions, and terminations; lack of active control groups; and an emphasis on surrogate rather than clinical outcomes.

“To improve the timeliness, quality, and availability of post-marketing evidence,” the authors conclude, “FDA should consider requiring post-market randomized clinical trials that use clinical endpoints. FDA should also consider implementing time-limited device approvals, whereby continued marketing would be contingent on timely generation and reporting of clinically meaningful post-approval data.”