IiiThe Center for Devices and Radiological Health

The CDRH is in some respects more directly involved with the regulation of devices. The scope of what is encompassed by the definition of "medical device" under these auspices is very broad. "Devices" can range from something as simple as a tongue depressor to a very complex piece of robotic machinery that performs remote surgery and involves the coordination of numerous complex functions that are controlled by sophisticated software. Nanotechnology is a ripe discipline for incorporation into many medical devices. The ability to use MEMS and NEMS structures in medical devices may contribute to further miniaturization of devices, rendering them considerably less invasive than many currently used devices.

The CDRH itself classifies devices into one of three categorizations that reflect a judgment on the level of risk presented by a particular device. Class I devices are those that present the lowest level of risk and are subject only to "general controls." Class II devices present a greater level of risk and are subject to "specific controls." Those devices that present the greatest level of risk—Class Ill devices—are subject to relatively stringent evaluation, requiring adherence to various strict conditions on manufacturing of the devices and requiring explicit and informative labeling.

But in addition to regulating medical devices, the CDRH also regulates devices that emit radiation. Some devices will fall within both categorizations, but most devices that emit radiation will not have particular medical applications. And the term "radiation" itself is relatively broad, encompassing not only electromagnetic radiation but also acoustic radiation. Examples of radiation-emitting devices that are regulated by the FDA through the CDRH thus include not only such devices as tanning lamps, welding equipment, and remote-control devices that emit electromagnetic radiation, but also sound amplifiers, sonic drills, and sonic-based jewelry cleaners, among thousands of other products.

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