September 28, 2017
The U.S. Food and Drug Administration (FDA) announced on Tuesday the names of companies chosen to participate in a new digital health software precertification pilot program.
The first-of-its kind pilot program is designed to help revolutionize digital health regulation and is intended to inform a tailored approach toward digital health technology.
The growth of digital health products—from health trackers built for specific tasks to software built for Apple Watches, cell phones and contacts that measure bodily function while correcting vision at the same time—has offered new ways for people and doctors to track health.
Along these lines, Apple CEO Tim Cook has been testing a prototype glucose-tracker that may be part of the Apple Watch. The device, which he said is a non-invasive and continuous glucose monitor that could be revolutionary for patients with diabetes.
The FDA’s Pre-cert pilot program will include technology giants such as Apple, Fitbit, Samsung and Verily, a division of Google’s parent company Alphabet, in addition to Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche and Tidepool.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, said in a press release.
“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. The diversity of the Pre-cert pilot program participants means that we will receive a variety of input on how the industry defines organizational excellence and other key performance indicators.”
The goal of the program is to determine the key metrics and performance indicators for precertification and identify ways that the pre-certified companies can submit less information to the FDA than what is currently required for approval to market a new digital health tool.
The agency is also considering whether pre-certified companies should be permitted to skip the submission of a product for premarket review in some cases, and how such a process would work.
Dr. Scott Gottlieb, commissioner of the FDA, said participants in the program will be helping the agency shape a more agile approach toward the development of digital health technology focused on software developers, rather than just individual products.
Participants will provide access to measures they currently use to develop, test, and maintain their software products along with how they collect post-market data. They will also receive site visits from FDA staff and provide information about quality management systems.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA Commissioner Dr. Scott Gottlieb said. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
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