AAMI News November 2017

Big Names in Tech Included in FDA Digital Health Pilot

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.

Big Names in Tech“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: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily, the life sciences arm of Google parent Alphabet Inc.

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. Pre-cert 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’s blog when the program was announced in July.

The FDA intends to solicit feedback throughout the pilot program, including a public workshop scheduled for January.