Apple, Fitbit, Samsung Join FDA Program

a smartwatch showing the wearer's heart rate.

The FDA plans to give pre-certification to companies that develop devices designed to monitor the wearer’s health. Apple and Fitbit are among the nine participants in the program.

Apple, Fitbit, and Samsung have been named as participants in a program by the US Food and Drug Administration (FDA), which plans to speed up the regulatory approval process for digital devices that monitor the wearers’ health.

According to the FDA press release, there were around 100 companies that volunteered to be a part of the program. Other companies included in the program were Johnson & Johnson, and Verily, which is Alphabet Inc’s biotech unit.

The “first-of-its-kind” pilot program is said to help “revolutionize” digital health regulation in the US. This program allows companies to get their product “pre-cleared” instead of going through the agency’s standard application and approval process, which usually takes months to finish.

“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” said FDA Commissioner Scott Gottlieb.

In the pilot program, the FDA will look at the software developer or digital health technology developer instead of the product, with the goal of determining whether the company meets the standards of the FDA. If the company passes, its product will be pre-certified.

“With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA,” the statement said.

Recently released devices, like the Apple Watch or Fitbit’s Ionic, are designed to measure and/or monitor things like motion and heart rate. However, for them to be able to take further measurements like blood oxygen or glucose, devices will have to fall under a process that will make sure it’s using sound quality metrics.

Apple Inc is studying whether its Apple Watch can detect heart abnormalities. Verily is working with Novartis AG to develop a specialized contact lens that could continuously monitor the wearer’s blood sugar.

“Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” said the agency’s commissioner in July during the initial announcement of the pilot program, which is formally called the Pre-Cert for Software Pilot. Gottlieb at that time branded it “a new and pragmatic approach to digital health technology.”

This program is a part of a broader move by the FDA since Gottlieb became the commissioner in May. Aiming to streamline regulation and deliver medical products to patients faster, Gottlieb said last week that FDA would clarify the way drugmakers can use data from treatments.

In the past, a variety of health product developers had to deal with multiple roadblocks as the FDA attempted to figure out how to regulate uncharted territories. For instance, DNA testing service 23andME had to halt the sales of its at-home kit in 2013. The sales were approved only earlier this year to detect genes linked to certain medical conditions. Other instances reportedly took more than a year to conclude.

“We are hopeful this will allow us to accelerate FDA regulated features and software development, bringing new capabilities that could positively impact health outcomes to market more quickly,” said chief executive officer James Park of Fitbit, which has recently unveiled its new smartwatch.

The FDA plans to share to the public the updates about the pilot program via the program’s webpage as well as through stakeholder meetings, including a workshop in January 2018. Through the entire program, the FDA will receive feedback from the nine selected participants, stakeholder groups, and the public.

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