WASHINGTON — The Food and Drug Administration is working with nine heath companies to learn more about medical software development so that the agency can consider allowing companies to sell software with less, or perhaps, no evaluation of the software itself before it goes to market, the agency announced Tuesday.
The nine companies, whose products range from fitness trackers to diagnostic test development, are helping the FDA develop a pre-certification program, dubbed “FDA Pre-cert,” which would shift the agency’s focus from evaluating products to evaluating producers. If a company demonstrates that it meets certain to-be-determined markers of quality, then it could be subject to less regulation.
