FDA Updates Software Precertification Program

The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health and safety.

The agency announced a pilot program in July 2017 and in September 2017 named nine participants selected for the pilot, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Alphabet’s Verily.

Participants in the pilot program agreed to provide information on how they develop, test and maintain their software products and on their quality management systems. They also committed to being available for site visits from agency officials.