3 questions nagging legal experts about the FDA’s software precertification program

Amid the excitement around the FDA's software precertification pilot, legal experts wonder if it will actually work.

As the digital health industry revels in the Food and Drug Administration’s new approach to digital health, legal experts are tossing a bit of skepticism toward the regulatory framework.

Last month, FDA Commissioner Scott Gottlieb unveiled the FDA’s new Software Pre-Cert Pilot Program designed to streamline the regulatory process for digital health software. Industry executives, already elated by the FDA’s June announcement that it was finalizing a Digital Health Innovation Plan, were impressed by the speed at which the agency has moved forward with a precertification program that senior officials had been hinting at for some time.

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But the new regulatory approach “raises as many questions as it answers,” three law professors at Southern Methodist University, Indiana University and Harvard wrote in a Health Affairs Blog post. Some of those questions include:

  • Will a third-party approach to certification be effective? (The authors pointed to shortcomings within the EHR certification program as an example).
  • Will the new plan generate enough evidence to garner trust among users, and will the FDA incorporate traditional oversight functions when necessary?
  • How will the FDA execute the plan without the legislative support of the 21st Century Cures Act, which doesn’t specifically call for the precertification program? (The authors note the plan “will likely be implemented through nonbinding guidance.”)

Ultimately, the authors see some potential weaknesses in the agency’s shift that could have “important ramifications” for each member of the healthcare ecosystem.

“Under a new administration, the FDA is experimenting with a new way to balance innovation and risk with emerging medical technologies,” they wrote. “The big question is whether the experiment will generate evidence that potential users can rely on.”