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FDA Announces Pilot Participants in Technology PreCert Program


The FDA has announced the 9 companies that will participate in a pilot precertification program to speed the approval of digital health software.

Two months after outlining a precertification program to speed the approval of digital health software, the FDA has announced the 9 companies that will participate in the pilot program, which include tech industry giants, software startups, and pharmaceutical manufacturers.

In late July, FDA commissioner Scott Gottlieb, MD, unveiled the agency’s blueprint for a Digital Health Software Precertification (PreCert) Program. This program would allow for quicker approval of health software tools released by trusted developers, instead of making them wait for a full review of each product. The traditional process was a poor fit considering the innovative nature of health technology, Gottlieb wrote, and he hoped to help the agency function more like Silicon Valley than Big Pharma.

Both of those entities were represented among the 9 companies selected to take part in the pilot phase of the PreCert program. Technology behemoths Apple, Samsung, and Verily (Google’s life sciences division) will participate, as well as newer digital startup companies: Phosphorus, which harnesses big data to understand the human genome, and Tidepool, a nonprofit that makes diabetes data more accessible to patients and researchers. Fitbit, which makes wearable health trackers, also joined the roster.

Multinational pharmaceutical companies Johnson & Johnson and Roche will be included in the pilot. Another member, Pear Therapeutics, also develops FDA-approved products, but in the prescription digital therapeutic space. Its reSET system featuring a mobile app for patients and a web interface for clinicians recently gained marketing approval from the FDA to help treat substance use disorders.

Though these companies vary in size, industry, and mission, they share common qualities that led the FDA to select them out of over 100 companies that expressed interest in participating in the PreCert program. They have each demonstrated a record of high organizational quality while advancing unique and innovative approaches to digital health, according to the FDA’s announcement.

“The diversity of the PreCert pilot program participants means that we will receive a variety of input on how the industry defines organizational excellence and other key performance indicators,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, in the statement. “This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”

The feedback will be collected by the FDA during site visits and other data collection endeavors. Participants have agreed to give the agency access to their software development and testing measures, postmarket follow-up strategies, and insights on their quality management system. The FDA wrote that it will welcome input from the pilot participants and other interested parties throughout the duration of the pilot, and plans to hold a stakeholder workshop in January 2018.

“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,” said Gottlieb in the statement. “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.”

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