Device Regulation

Like pharmaceuticals, medical devices are heavily regulated. The FDA is the chief regulatory body in the United States. The European Union, Canada, and other countries have their own requirements which must be met in order to market a device in those countries.

The FDA's Center for Devices and Radiologic Health (CDRH) has primary responsibility for approving medical devices for the market; collecting and acting on information about radiation-emitting products and device-related injuries; setting and enforcing good manufacturing practice (GMP) standards and performance regulations; monitoring compliance and surveillance programs; and providing technical assistance to manufacturers.

Medical devices may be marketed for sale in the United States after receiving either a premarket notification 510(k) or premarket approval (PMA) from the FDA.

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