Revised Guidance Documents Mark Changes in FDA’s Policies for Regulating Digital Health Products
October 2, 2019 at 02:33 PM EST
The FDA Sept. 26 released a set of revised guidance documents intended to clarify the scope of the agency’s regulatory authority and its policies with respect to digital health technologies following the enactment of the 21st Century Cures Act.
The documents include revised information on which devices previously placed within the scope of the FDA’s enforcement discretion (me... Read More
