Senate Special Committee on Aging Chairman Herb Kohl, D-Wis., is considering legislation to restrict direct-to-consumer advertising of medical devices
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
