FDA's digital health pre-certification pilot program is now open for applications

The focus of the Pre-Cert program is not on particular products but on firms and developers, which in turn (if pre-certified) will be able to more easily certify all of their products.

FDA's digital health pre-certification pilot program is now open for applications

The FDA has opened up applications for the nine-company pilot to develop a pre-certification program for digital health app developers.

The focus of the Pre-Cert program is not on particular products but on firms and developers. So if the FDA is "satisfied" with the firm, it won't regulate each of its products, making the process of certifying multiple apps that much faster.

From FDA's blog post:

Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a premarket submission at all. In those cases, the pre-certified company could launch a new product and immediately begin post-market data collection. Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable. The post-market data could help FDA assure that the new product remains safe and effective as well as supports new uses.

Applications for the pilot begin August 1 when the FDA will also host a webinar to answer questions and give more information about the program.

The FDA is looking for a diverse group of applicants:

Initial participants in this new pilot will range from small startups to large companies that develop both high- and low-risk software products that are devices. We want to include medical product manufacturers as well as non-traditional software developers. Given the amount of attention we're getting, and the ongoing innovation in this space, I'm confident we'll have strong participation in the new pilot.

It is, however, not clear what benefit will companies get out of participating in the pilot. We would assume they will be among the first ones to be pre-certified, making their job of certifying each of their devices and apps much easier in the future. We hope to get more information about this soon. Stay tuned in the meantime…

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