Here are five notes on the pre-cert program:
1. The FDA launched the pre-cert program in 2017 to streamline the approval process for digital health products, such as devices that use artificial intelligence. The development program reviews developers — rather than individual products — with the underlying premise that digital health products should be evaluated differently than traditional medical devices, since software is frequently updated.
2. In the pre-cert program’s initial pilot, tech giants like Apple and Fitbit provided the FDA with insights into how they develop, test and maintain their software products, as well as how they collect post-market data. The agency plans to launch a large-scale pilot of the program this year, building on lessons learned during the initial pilot.
3. In 2019, the FDA will pursue two new phases to evaluate the pre-cert program. First, the agency will review previous software approvals to determine whether the regulatory framework outlined in the pre-cert program would have obtained enough information to make a proper decision. Second, the FDA will test its pre-cert model on some new software submissions.
4. The FDA also plans to test additions to its process of collecting post-market data in 2019. The agency will encourage developers and reviewers to share data to help monitor the performance of software that’s already been approved. A series of unsuccessful reviews might jeopardize the developer’s pre-cert status, according to Politico.
5. If the FDA’s pre-cert program proves successful in pilot rollouts, the agency said it will seek new congressional authority to implement it.
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