FDA Names Digital Health Pilot Program Participants

The U.S. Food and Drug Administration (FDA) has selected nine companies to participate in its digital health technology and software precertification pilot program.

The pilot program is part of the FDA’s Digital Health Innovation Plan, which was announced earlier this year and is intended to facilitate greater market access for new and advanced healthcare technologies. The goal of the precertification pilot program is to explore a new approach to the regulation of advanced medical technologies by qualifying eligible digital health developers.

Developers selected to participate in the precertification pilot program were required to demonstrate “a culture of quality and organizational excellence based on objective criteria.” Those meeting that criteria and selected to participate in the pilot would then be able to market certain low-risk devices without additional FDA review or with a more streamlined premarket review.

According to an FDA press release issued in late September, the selected companies include “small startup and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.” The companies are:

  • Apple
  • Fitbit
  • Johnson & Johnson
  • Pear Therapeutics
  • Phosphorus
  • Roche
  • Samsung
  • Tidepool
  • Verily

The FDA says it will provide periodic updates on the progress of the pilot program through the agency’s website.

Read the text of the FDA’s press release announcing the selection of the pilot program participants.


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