Zdrowie i gospodarka · 30/12/1998

FDA Issues Final Rule Requiring Premarket Approval for Certain Dental Devices

The FDA is requiring manufacturers to submit premarket approval applications or product development protocols for specific dental devices, including TMJ and glenoid fossa prostheses, due to the FDA Modernization Act of 1997 and the Medical Device Amendments of 1976. This rule aims to improve the safety and effectiveness of these devices.