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On July 27th, the FDA announced the Digital Health Innovation Action Plan and the launch of the agency’s Software Precertification Pilot Program.

The Digital Health Innovation Action Plan provides details and timelines for FDA’s integrated approach to digital health technology and the implementation of the 21st Century Cures Act. The Software Precertification Pilot Program is a voluntary pilot program that will enable FDA to develop a tailored approach toward recognizing the unique characteristics of digital technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we currently do for traditional medical products. This pilot is an important first step to help FDA explore and evaluate elements that might be appropriate for a future precertification program, and explore whether and how precertified companies that have demonstrated a culture of quality, patient safety, and organizational excellence could be able to bring certain types of digital health products to market without FDA premarket review or after a more streamlined FDA premarket review. The application to participate in the pilot program will open August 1. Additional information can be found on the Digital Health Webpage.

Target Audience: Industry