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# Legislation for More AI/ML Flexibility Needed: Shuren
- URL: https://www.fdaweb.com/legislation-for-more-ai-ml-flexibility-needed-shuren/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:38:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151448

CDRH director **Jeffrey Shuren** says he would like to see legislative changes that would give the Center greater regulatory flexibility in dealing with artificial intelligence/machine learning (AI/ML)-driven medical devices. Speaking to a 3/22 Duke Margolis Center for Health Policy [Webinar](https://youtu.be/DtVBY4CrMeQ?t=4648&ref=fdaweb.com) on regulation, development, and real-world performance evaluation of AI/ML, Shuren noted that many of the regulatory pathways available to CDRH were developed decades ago to meet the technology that was available then. He said that it will be important in the future to have greater regulatory flexibility and agility so the Center can create pathways that are better for innovative technology.

In his presentation, Shuren said the Center’s AI/ML action plan approved in 2021 was an “invitation to collaborate \[issued\] to a broad range of stakeholders.” He noted that CDRH is active in several collaborative communities in the digital health space, having committed to participating in at least 10 such communities. “Such an approach is going to become business as usual for us,” he said.

Shuren also stressed the importance of transparency as a factor that leads to informed decisions by patients and healthcare professionals, safe and effective device use, health equity, monitoring device performance, and trust.