- The FDA has selected nine companies to participate in its digital health software precertification pilot program.
- Companies include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsumg, Tidepool and Verily.
- The program will review a developer, instead of a product, to determine if a company meets quality standards and should be precertified.
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 could avoid submitting a product for premarket review in some cases. "We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate," FDA Commissioner Dr. Scott Gottlieb said at the time of the announcement.
It's all a part of a larger effort to reimagine how the FDA approaches digital health medical device regulation. Consumer technology has been making great strides since the iPhone launched in 2007 and changed how consumers interact with technology on a day-to-day basis. However, medical device regulation under the FDA's watch hasn't been updated to reflect this change.
On one hand, this can be frustrating for companies who see a business opportunity in the healthcare space. However, because healthcare is an industry that affects individuals' lives and health, it is heavily regulated — and rightly so.
But the FDA is looking to retool how it regulates low-risk medical devices in hopes to foster innovation in the digital health space. Precertification is a pilot program but, given the pedigree of the participants, many vendors will be watching the results.
The agency plans to share public updates about the pilot program via the pilot program webpage, as well as through stakeholder meetings.