Category: US FDA

US FSA – Surgical staples – Guidance and proposed rules

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Draft Guidance for Industry […]