FDA Publishes List of 1000+ Class II Devices Exempt/Partially Exempt From 510(k) Requirements

Received from CDRH July 10, 2017: “Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical device industry and reduce private costs and expenditures required to comply with federal regulation, the FDA is exempting or partially exempting (exempting with limitations) these devices from the premarket notification [510(k)] requirements. The list of exempted device types is final upon publication. This announcement follows streamlined procedures established by the 21st Century Cures Act. Click here to see the Federal Register Notice, which includes the story and the list, or here for help with your medical device development program.