The US Food and Drug Administration (FDA) is responsible for regulating and supervising the safety of medical devices and radiation-emitting products.
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms engaged in manufacturing, repackaging, relabeling, and/or importing medical devices sold in the United States. CDRH also ensures the safety and effectiveness of medical devices, as well as protecting against unnecessary exposure to radiation-emitting products.
FDA classifies medical devices into three classes – Class I, Class II and Class III. The device class identifies the level of regulatory control necessary to ensure the safety and effectiveness of a medical device, as well as the applicable marketing process in order to obtain FDA clearance/approval. Class I devices are considered “low-risk”, Class II devices require “general controls and special controls”, and Class III require pre-market approval (PMA).
FDA Solutions Group offers assistance with the following registration and compliance requirements:
Medical Device Establishment Registration
Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA on an annual basis. Medical device facility registration information must be verified annually between October 1st and December 31st of each year. Click here to get started.
Class I Medical Device Listings
Most establishments that are required to register with the FDA are also required to list the devices and the activities that are performed on those devices. Click here to get started.