FDA publishes new premarket notification requirements for reusable devices

In compliance with the 21st Century Cures Act of 2016, the U.S. Food and Drug Administration (FDA) published a list of reusable medical devices that must include with their 510(k) premarket notification validated instructions for use, as well as validation data regarding cleaning, disinfection, and sterilization. These devices, which FDA believes have the greatest risk of infection transmission if not adequately reprocessed, include many types of scopes and accessories, water-based heater-cooler systems, and automated reprocessors for reusable devices. The FDA notice also includes a list of design features which may pose a challenge to adequate reprocessing. Compliance with the new 510(k) requirements is effective August 8, 2017. Read the FDA notice.