New Digital Health policies by US FDA to encourage innovation, efficiency & modernization - Digital Intent


Tuesday, 12 December 2017

New Digital Health policies by US FDA to encourage innovation, efficiency & modernization

US FDA issued the Digital Health Innovation Action Plan, which outlines its efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, it is committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies. 

The US FDA announced 3 new , significant policy documents to advance its approach to the development and proper oversight of Innovative Digital Health Tools

It will be taking other steps to implement its Digital Health Innovation Action Plan. It is hosting a Pre-Cert Pilot Program workshop on January 30-31, 2018  to update FDA staff, participants and stakeholders on the lessons learned from the pilot.

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