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# Require Better De Novo Evidence: Researchers
- URL: https://www.fdaweb.com/require-better-de-novo-evidence-researchers/
- Published: 2020-10-13T12:00:00.000Z
- Updated: 2026-09-14T16:32:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147859

Researchers from Yale University and the University of California San Francisco say that FDA could ensure that better evidence is generated to guide clinical decision-making by requiring that medical devices cleared through the *de novo* pathway meet prespecified effectiveness endpoints for clearance. They also say that postmarket studies should include larger patient populations.

Writing in a *JAMA Internal Medicine* Research Letter, the authors [say](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2771667?resultClick=1&ref=fdaweb.com) that the larger postmarket studies “could be particularly informative for devices cleared without pivotal studies and those that failed to meet effectiveness endpoints.”

The researchers say that between 2011 and 2019, FDA cleared most novel moderate-risk therapeutic devices via the *de novo* pathway based on pivotal clinical studies. However, they say, some 20% of devices were cleared without pivotal clinical studies, and some 33% were based on pivotal studies that failed to meet at least one primary endpoint.

“Nevertheless,” the report says, “FDA rarely required postmarket studies and devices cleared through the *de novo* pathway often served as the basis for new models and competitor products subsequently cleared via the 510(k) process.”