FDA Selects Participants for Pre-Certification Software Pilot | Practical Law

FDA Selects Participants for Pre-Certification Software Pilot | Practical Law

The FDA announced the nine companies it selected to join the Pre-Certification for Software Pilot Program.

FDA Selects Participants for Pre-Certification Software Pilot

Practical Law Legal Update w-010-6763 (Approx. 2 pages)

FDA Selects Participants for Pre-Certification Software Pilot

by Practical Law Life Sciences
Published on 04 Oct 2017USA (National/Federal)
The FDA announced the nine companies it selected to join the Pre-Certification for Software Pilot Program.
On September 26, 2017, the FDA announced the participants it selected for the Pre-Certification for Software Pilot Program. The program, which was launched as part of the FDA's Digital Health Innovation Action Plan (see Legal Update, FDA Announces New Initiatives for Digital Health Devices), pre-certifies software developers who excel in developing and testing lower-risk digital health devices without additional FDA review.
The companies selected are:
  • Apple Inc.
  • Fitbit, Inc.
  • Johnson & Johnson, Inc.
  • Pear Therapeutics, Inc.
  • Phosphorus, Inc.
  • Roche Holding AG.
  • Samsung Electronics Co., Ltd.
  • Tidepool, Inc.
  • Verily Life Sciences LLC.
As part of the program, the companies have agreed to:
  • Provide the FDA access to measures to develop, test, and maintain software products, including post-market data collection methods.
  • Be available for FDA site visits.
  • Provide the FDA information on quality management systems.
The FDA will provide public updates about the pre-certification pilot program on its website and at public meetings, including at a workshop in January 2018. The FDA plans to seek comments on the program from participants and the public.