The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications.
In 2017, the FDA released its Digital Health Innovation Action Plan, while also unveiling a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products.
The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said at the time.
