FDA unveils Digital Health Pre-Certification Program

The FDA today revealed its Digital Health Innovation Action plan, including a new software Pre-certification Program through which the FDA would shift its regulatory focus from the product to the developers for digital health companies.

The federal watchdog said that the program looks to shift its oversight of digital health software and tech as software products are generally produced quickly and through iterative design, development and validation processes that its traditional oversight strategies are not well suited for.

In its Digital Health Innovation Action Plan, the FDA said the recertification program could replace the need for premarket submission for certain products and would allow for lessened submission content and possible faster reviews for other products.

Through the program, the FDA’s Center for Devices and Radiological Health could ‘pre-certify’ digital health dev who “demonstrate a culture of quality and organizational excellence based on objective criteria, for example, that they can and do excel in software design, development and validation (testing)” the agency wrote.

After pre-certification, developers could market low-risk devices and software without further FDA review, or a more streamlined premarket review. Streamlined review could include reduced submission content and faster review from CDRH staff.

Pre-certified companies would also have access to the National Evaluation System for health Technology, designed to “generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices,” the FDA said.

The agency said that part of its intention with the pre-certification program is to gather customer input to develop a program to reduce time and cost for software developers, while applying appropriate safeguards for patients.

To facilitate the program, the FDA said it will hire on new staff  within the CDRH as it looks to “build a cadre of experts with a deep understanding and experience with software development and its application to medical devices.”

The FDA said it will be hosting a webinar on the new pre-certification program on Aug. 1, and encouraged individuals interested in a pilot version of the program to join.

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