21st Century Cures Act


CDS, PDS and FDA

By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).







The Cures Act and Software

By William Hyman – The current version of the 21st Century Cures Act, which has been around in various forms since 2014, passed the House on November 25th and passage in the Senate is expected.