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Tuesday, September 26, 2017
Apple, Fitbit and Samsung Join FDA's Digital Health Software Precertification Program

The Food and Drug Administration (FDA), which oversees new drugs, medical devices and much of the U.S. food supply, said Tuesday that it had selected nine major tech companies including Apple and Fitbit for a pilot program that may let them avoid some regulations that have tied up developers working on health software and products.

FDA Commissioner Scott Gottlieb, M.D. announced today the nine participants, who include leaders in the medical device and technology sectors, of the FDA's digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

The FDA's Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product. The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company. With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program. The FDA is also considering, as part of the pilot program, whether and how, precertified companies may not have to submit a product for premarket review in some cases.

Participants selected include:

Johnson & Johnson
Pear Therapeutics

In selecting the participants, the agency said it considered several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product.

As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system.

The FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage as well as through stakeholder meetings, including a January 2018 workshop. Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.

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