US FDA Asks For Public Input On Software It Can't Regulate

30 May 2018

FDA is writing a report on key safety impacts from health software products that fall outside of its regulatory purview under the 21st Century Cures Act. To help the effort, the agency is asking industry, patient groups and other stakeholders to chime in by June 28.

The 21st Century Cures Act placed certain categories of health software, such as general wellness tools and electronic patient records, outside of US FDA's regulatory authority, but that doesn't mean the agency can completely ignore them. Congress required FDA to issue a report on the safety impacts of these non-regulated software categories, and now the agency is asking for input from industry, patient groups and other stakeholders on the topic.

The Cures Act, enacted in 2016, specifically precludes five categories of software from FDA device regulations: