Medical Devices

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 Medical Device Services

• Domestic Medical Device Establishment Registration: for establishments located in the United States that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S. 
• Foreign Medical Device Establishment Registration: for establishments located outside of the United States that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S. 
• Medical Device Listings: for most establishments required to register with the FDA.