FDA Commissioner Outlines Next Steps for Pre-Cert Digital Health Pilot Program

January 8, 2019


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.

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