The US Food and Drug Administration (FDA) regulates and supervises the safety of medical devices and radiation-emitting products.

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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.

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FDA classifies medical devices into three classes – Class I, Class II, and Class III. The class of a device 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 finally, Class III devices require pre-market approval (PMA).

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From medical device classification and establishment registration to necessary submissions, Provision Consulting Group provides all of the services necessary to enter the U.S. marketplaces with your medical devices.