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# FDA ‘Ambiguous’ Digital Health Enforcement Discretion
- URL: https://www.fdaweb.com/fda-ambiguous-digital-health-enforcement-discretion/
- Published: 2021-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:48:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148754

Participants in a 2/24 DTx West virtual panel said a growing number of digital health companies “are finding themselves in a gray area of enforcement discretion, a term FDA uses for lower-risk products that meet the definition of a medical device but do not require regulatory submission, review, and authorization before heading to market.” *Mobile Health News* [reports](https://www.mobihealthnews.com/news/fdas-enforcement-discretion-digital-health-more-ambiguous-ever-2021?ref=fdaweb.com) that the problem, panel members said, is that enforcement discretion, on the whole, can be ambiguous when dealing with novel products that the agency may not have foreseen when putting together its initial guidelines years ago.

“Enforcement discretion doesn’t mean no regulation,” Big Health vice president of regulatory affairs and quality **Ankur Kaushal** said. “It doesn’t mean that FDA is no longer in your life. FDA is very much there. Regulations are still very much present. FDA is choosing to enforce in a very hands-off manner and so, instead of getting clearances and approvals, you’re able to move forward by internally building evidence that you are complying.”

Panelists said that while FDA has made some progress recently by publishing action plans specific to new technologies like artificial intelligence and machine learning, issues like the Covid-19 public health emergency and new policies regarding modifications to current products have driven home the need for more guidance from the regulator.

“The principles of enforcement discretion have been outlined for some time, but I think there has been a need for increasing regulatory clarity over the past couple of years,” said former CDRH senior advisor for digital health **Marisa Cruz**, now Everywell executive vice president. “There are many more companies that have been touched by this distinction between active regulation and enforcement discretion, and I think the agency has tried to support that broader reach of enforcement discretion policies with more active articulation of what enforcement discretion really means…. It’s still evolving and I think it’s still spotty as to the consistency of how these policies are applied, and how companies are interpreting ways to distinguish products that are the focus of regulation from those that are under enforcement discretion.”