FDA announces Digital Health Innovation Action Plan

Today, the FDA announced the formal launch of the Pre-Cert for Software Pilot Program and published their Digital Health Innovation Action Plan.

The Digital Health Innovation Action Plan (PDF) provides details and timelines for the integrated approach to digital health technology and the implementation of the 21st Century Cures Act.

The goals are to:

• enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
• ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
• be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

Learn more at the FDA Blog.