Pursuant to section 513(d) of the FD&C Act (21 U.S.C. 360c(d)), FDA promulgates classification regulations classifying devices by generic type. A “generic type of device” is “a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.” (See 21 CFR 860.3(i)). FDA has issued regulations classifying the vast majority of pre-amendments devices (devices that were in commercial distribution before May 28, 1976) by generic type of device. See 21 CFR 860.84. Each classification regulation, located at 21 CFR parts 862-892, indicates in which class (I, II, or III) FDA has classified the device type. While the great majority of device classifications codified in 21 CFR parts 862-892 are of pre-amendments devices, some of these classifications are of post-amendments devices.

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