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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