Most medical devices can be classified by finding the matching description of the device amongst one of the 16 medical specialty “panels” listed in Title 2138 of the Code of Federal Regulations. For each of the devices classified by the FDA, the CFR gives a general description including the intended use, the class to which the device belongs (i. e., Class I, II, or III), and information about marketing requirements.
It is a point to be noted that manufacturers do have, to a certain degree, the right to contest the classification of a device, and to petition the FDA for changes relative to a device’s classification.39
To find the classification of a device, as well as to know whether any exemptions may exist, you need to locate the regulation number that is the classification regulation for the device of interest. There are two methods for accomplishing this: go directly to the classification database40 and search for a part of the device name, or, if you know the medical specialty (device panel) to which the device belongs, go directly to the listing for that panel and identify the device and the corresponding regulation.
Each classification panel in the CFR list those devices classified in that panel. Each classified device has a 7-digit number associated with it, for example, 21 CFR §878.48 1 041— Laser Instrument, Surgical. Once you find your device in the panel’s beginning list, go to the section to determine the assigned class. Similarly, in the Classification Database under “laser”, you will see several entries for various types of lasers. The three – letter product code, GEX in the database for Laser Surgical Instrument is also the classification identifier which is used on the Medical Device Listing form, FDA-2892.42