J&J, Roche among companies selected for FDA digital health pilot
- The FDA has selected nine companies to participate in a digital health software precertification pilot program, taking another step forward in its effort to experiment with how it reviews new tools like mobile apps.
- Companies selected include both tech and pharma giants, such as Apple Inc, Roche AG and Johnson & Johnson, as well as lesser-known names like Pear Therapeutics.
- The program will review a developer, instead of a device, to determine if a company meets quality standards and should be precertified for faster product review
The FDA hopes the pilot will give it the information it needs to shape a broader precertification program, aiming to identify ways companies could potentially submit slimmer applications to the FDA before marketing new digital health software or devices.
Also under consideration through the pilot is whether companies that receive a precertification might be able to skip out of submitting a product for premarket review in certain, likely lower-risk, cases.
"We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate," FDA Commissioner Scott Gotllieb said in a Sept. 26 statement.
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, changing how consumers interact with technology on a day-to-day basis. However, medical device regulations under the FDA's watch haven't been updated to reflect this change.
This can be frustrating for companies who see a rapidly evolving business opportunity in the healthcare space. However, as healthcare is an industry that affects individuals' lives and health, it is heavily regulated — and rightly so.
Still, the FDA is looking to retool how it regulates low-risk medical devices in hopes to foster innovation in the space — a goal that has new momentum under Gottlieb. 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 via the pilot program webpage, as well as through stakeholder meetings.
- BioPharma Dive FDA chief Gottlieb maps out new digital health plan
- Healthcare Dive FDA begins digital health hiring efforts
- Food and Drug Administration Press release
- Food and Drug Administration Digital Health Innovation Action Plan
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