FDA Medical Device Regulations

fda medical devices

FDA Class I, Class II, Class III Medical Devices

FDA Administration’s Center for Devices and Radiological Health (CDRH) enforces a regulatory system for medical devices based on risk, dividing

fda regulations

FDA Regulations

Please find below a list of important documents published by the US Food and Drug Administration (FDA), which will help you better understand FDA

medical device 510k

Medical Devices Exempt from the 510k Procedure

FDA Class I Devices The FDA has exempted most Class I medical devices (except Reserved Devices) from the FDA 510(k) Premarket Notification,