Tuesday, 18 December, 2018

FDA selects participants for new digital health software precertification pilot program

The FDA Has Created an Approval “Fast-Track” for Apple, Samsung, and Fitbit New FDA rule may let Apple, Fitbit and Samsung fast-track health breakthroughs
Troy Mann | 28 September, 2017, 02:39

The Food and Drug Administration announced on Tuesday its plans to launch a pilot program for nine top tech companies, allowing them to avoid a few regulations that have been slowing down the release of software and products within the health industry.

Also among the names is Verily Life Sciences, the health unit of Alphabet, which also works with glucose tracker maker Dexcom. Most of these providers deeply invested in the development of new digital health technology devices and apps.

"Our method for regulating digital health products must recognize the unique and iterative characteristics of these products", FDA Commissioner Scott Gottlieb, M.D., said in a statement. Similarly Apple is now working with Stanford clinicians to research how the Apple Watch could detect abnormal heart rhythms, something that would most likely require FDA approval if it were to diagnose. The process it will go through to make sure it's using sound quality metrics and other measures won't be as costly and time-consuming as when the government clears a new pacemaker, for example. Other participants are Johnson & Johnson, Roche, New York's Phosphorus, Palo Alto-based Tidepool, and Pear Therapeutics from Boston.

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.

"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 executive added.

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In accounting the participating companies, the FDA noted that the participants represent a wide range of companies and technology in the digital health sector, including high- and low-risk medical device software products, medical product manufacturers and software developers. In July, he delayed oversight of electronic cigarettes while the agency decides what information it will need from makers of the products.

The FDA's Pre-cert pilot program is meant to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product, according to a FDA press release.

However, rather than focusing purely on products themselves, the FDA wants to be able to "pre-certify" companies that meet a set of standards for quality. The agency actively began hiring for its digital health team earlier this month.

In a statement about joining the Pre-Cert program, Park gave a little more detail about the company's future plans.

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