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Apple, Samsung join FDA pilot to speed up health service approval

Apple, Samsung join FDA pilot to speed up health service approval

Throughout the pilot, the FDA will solicit feedback from the selected participants, as well as from industry, stakeholder groups and the public.

As part of the Pre-cert pilot program, participants have agreed to provide access to measures they now use to develop, test and maintain their software products, including ways they collect post-market data.

"This is an effort to come up with a regulatory approach that is adapted to a fast-moving field", said FDA Commissioner Scott Gottlieb in an interview.

He opined, "We need to modernize our regulatory framework so that it matches the kind of innovation we're being asked to evaluate". A lot of the interested parties will be watching closely to see the progress the companies make.

Apple is studying whether its watch can detect heart abnormalities.

"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.

Apple is the provider of Carekit, Health, and ResearchKit, while Samsung has also tested the waters with the Samsung Health app.

Pear Therapeutics is a notable inclusion on the list for the fact that it just last week received a landmark de novo clearance for ReSet, its digital therapeutic for non-opioid addiction.

Precertification could eventually be a big boon for a company. Fitbit CEO James Park resorted to Twitter in celebrating his company making the cut.

"Look, I think it's a pretty massive opportunity", he said in an earnings call back in May 2016. "I think the great thing is that, due to our leadership position, we are very visible in Washington and I think we're going to have a big seat at the table in driving those discussions, so it's going to be a pretty big opportunity for us".

The program is part of a broader move at the FDA, particularly since Gottlieb took over in May, to streamline regulation and get medical products to patients faster. Ultimately the scale did receive FDA clearance, and later that scale would be included in a category of low-risk devices over which the agency exercises regulatory discretion. The FDA says more than 100 companies expressed interest in the pilot program.

Today, the U.S. Food and Drug Administration (FDA) announced it has selected Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Google's Verily to participate in the FDA's new digital health per-certification pilot program. 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.

Participating companies will have to provide FDA with access to their testing measurements, information about quality management and real-world data they have collected.

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