Zdrowie i gospodarka · 19/12/2002

FDA Proposes Special Control for Eight Surgical Suture Devices

The Food and Drug Administration (FDA) is proposing to amend the classification regulations for eight surgical suture devices, which were previously reclassified into class II, to specify a special control for those devices. The agency is seeking public comment on a guidance document that it believes will reasonably assure the safety and effectiveness of the devices.