Apple, Fitbit, Johnson & Johnson to Participate in FDA’s Digital Health Pilot Program

Posted September 27, 2017

Nine technology and device companies, including several well-known names, have been selected to participate in a Food and Drug Administration (FDA) pilot program intended to fast-track health software. By focusing on assessing the makers of software, not individual products, the FDA said it hopes to streamline the review process to help bring digital health products to market faster.

"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,” FDA Commissioner Scott Gottlieb said in a statement. “These pilot participants will help the agency shape a better and more agile approach toward digital health technology."

According to the FDA, more than 100 companies applied to be part of the precertification (Pre-cert) program, but just nine were selected based on factors such as company size, demonstrated record of quality and organizational excellence, clinical focus area, and the risk profile of the product. The selected companies are:

  • Apple, based in Cupertino, CA
  • Fitbit, based in San Francisco, CA
  • Johnson & Johnson, based in New Brunswick, NJ
  • Pear Therapeutics, based in Boston, MA
  • Phosphorus, based in New York, NY
  • Roche, based in Basel, Switzerland
  • Samsung, based in Seoul, South Korea
  • Tidepool, based in Palo Alto, CA
  • Verily, the life sciences arm of Google parent Alphabet Inc., based in Mountain View, CA

“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. “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. This feedback will be invaluable as we progress through the pilot and onto the next stages of digital health oversight.”

As part of the pilot, participants have agreed to provide access to measures they currently use to develop, test, and maintain their software products, including the collection of postmarket data. Participants also agreed to provide information about their quality management system and allow site visits by FDA staff.

“The goal of our new approach is for FDA to—after reviewing systems for software design, validation, and maintenance—determine whether the company meets the necessary quality standards and precertify the company. Precertified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, precertified companies could not submit a premarket submission at all,” Gottlieb wrote on the FDA blog when the program was announced in July.

The FDA intends to solicit feedback from the nine selected participants―as well as from industry, stakeholder groups, and the public―throughout the pilot process, including a public workshop scheduled for January.