Apple, Fitbit and Samsung selected to FDA’s new fast-lane program for health products

Apple, Fitbit, Samsung and Alphabet’s life sciences unit Verily have been chosen by the Food and Drug Administration to participate in a trial program allowing the companies to skip certain regulations to expedite innovation.

The FDA’s program will allow companies to pre-clear their products rather than going through the typical months-long standard application and approval process. Through this program, the  companies — all deeply invested in creating new digital health technology devices and apps — can introduce their products to the market much quicker.

This may bode particularly well for Apple and Fitbit, which are tackling widespread medical conditions through their wearables.

Cupertino-based Apple is working with the Stanford School of Medicine to help detect abnormal heart rhythm.  San Francisco-based Fitbit has been working on detecting sleep apnea.

FDA Commissioner Dr. Scott Gottlieb announced the program at the AdvaMed MedTech Conference in San Jose on Tuesday.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” said Gottlieb. “These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”

The FDA has courted health technology-focused companies to apply for the program since July. After two months of deliberation, the agency selected nine companies out of more than 100: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.

Switzerland-based Roche and South Korean tech giant Samsung were the only non-U.S. companies that made the cut.

“The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health.

Through the pilot program, the FDA hopes to collect information from the companies about  performance indicators for precertification. With a set criteria in the future, precertified companies may be able to submit less information to the FDA than is currently required for approval.

Apple did not immediately respond to a request for comment. Fitbit CEO James Park took to Twitter to celebrate his company making the cut.

“Proud that (Fitbit) is 1 of 9 companies out of 100+ selected to be part of the (FDA’s) new pre-cert pilot program,” tweeted Park. “Will allow us to launch digital health innovations more quickly.”

Photo: Apple Watches are seen on display during an Apple media event at the Yerba Buena Center for the Arts in San Francisco on March 9, 2015. (Josh Edelson/AFP/Getty Images)


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