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# Questions on New FDA Digital Health Approach
- URL: https://www.fdaweb.com/questions-on-new-fda-digital-health-approach/
- Published: 2017-08-16T12:00:00.000Z
- Updated: 2026-09-14T22:41:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139397

Writers of a *Health Affairs* blog post say FDA’s new approach to digital health — shifting from premarket to postmarket review by FDA and shifting from FDA oversight to oversight by independent, non-government certifiers — raises as many questions as it answers. The [post](http://healthaffairs.org/blog/2017/08/16/questions-about-the-fdas-new-framework-for-digital-health/?ref=fdaweb.com) says that the 21st Century Cures Act doesn’t seem to support the changes announced by FDA commissioner **Scott Gottlieb**. That legislation focused on clarifying FDA’s jurisdiction over software and does not contain authority to implement a new regulatory framework, they note

“FDA’s new plan will likely be implemented through non-binding guidance, a weakness previously identified by scholars and by Gottlieb himself,” the post says. “In fact, Gottlieb’s announcement hinted that third-party certification may be difficult to introduce under FDA’s current statutory authority.”

A second question raised is that although there remains significant demand among users and payers for reliable evidence to substantiate claims made by digital health products, it is not clear that the new plan will generate much evidence prior to market introduction. “If the shift from premarket review to postmarket evaluation is to be meaningful,” the post authors write, “it would be useful to specify a mandatory reevaluation by FDA at some regular interval, as is being contemplated in other countries.”

Finally, the authors say there are serious questions about the effectiveness of third-party certification. They say the agency is planning to create a new digital health unit of 13 engineers with expertise in software, artificial intelligence, etc., to coordinate agency review of digital health products. “It will be interesting to see whether that unit or third parties will generate the most reliable evidence that apps are safe and effective,” they comment. “The major shifts proposed by FDA represent an experiment in medical product regulation — with important ramifications for patients, clinicians, hospitals, payers, and product developers. Under a new administration, FDA is experimenting with a new way to balance innovation and risk with emerging medical technologies. The big question is whether the experiment will generate evidence that potential users can rely on.”