MobiHealth News October 19, 2018
A collaborative attitude and a commitment to strenuous review have characterized the process so far.
Attendees to the Connected Health Conference in Boston this week got a sneak peek into the workings of the FDA’s much-discussed Pre-Cert program. In a panel discussion at the event, representatives from Verily, Pear Therapeutics, Tidepool, and Johnson & Johnson candidly discussed their experiences so far with the program, describing an evolving process that is collaborative and rigorous.
“For me, the key takeaway is FDA is really committed to this, they’re in the weeds,” Dave Amor, VP of quality and regulatory affairs at Pear Therapeutics, said. “…The tone of the engagement with FDA during this process has been not combative, not antagonistic; it’s been...
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