The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs, who offer up three questions about the direction of the plan.
First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not include new authority to implement a new regulatory framework for software, though it does clarify FDA’s jurisdiction over software. According to the Cures deliverables, FDA has to issue a report by December 2018 clarifying medical software regulation.
"Thus, the FDA’s new plan will likely be implemented through nonbinding guidance, a weakness previously identified by scholars and by Gottlieb himself. In fact, Gottlieb’s announcement hinted that third-party certification may be difficult to introduce under the FDA’s current statutory authority," the professors write.
Second, although there is "significant demand" among users and payers for reliable evidence to substantiate digital health claims, "it is not clear that the new plan will generate much evidence prior to market introduction," they write, noting the shift away from premarket review.
And if FDA is going to make this shift, they say, it could use "a mandatory reevaluation by the FDA at some regular interval, as is being contemplated in other countries," they add.
Finally, the professors raise "serious questions about the effectiveness of third-party certification. For example, the certification process for ensuring that electronic health records satisfy ‘meaningful use’ standards has had decidedly mixed results. In the digital health sphere, an early certification effort was suspended after serious flaws were discovered in some of the apps that had been certified."
The article comes as FDA in May said it would create a new digital health unit and later that it would sign off on low-risk digital health products without premarket review.
"The major shifts proposed by the FDA represent an experiment in medical product regulation—with important ramifications for patients, clinicians, hospitals, payers, and product developers. Under a new administration, the 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," they concluded.
Questions About The FDA’s New Framework For Digital Health
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