Reference: (FDA Devcie Classification, 2014)
To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device. There are two methods for accomplishing this: go directly to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation. You may make a choice now, or continue to read the background information below. If you continue to read, you will have another chance to go to these destinations.
If you already know the appropriate panel you can go directly to the CFR and find the classification for your device by reading through the list of classified devices. If you're not sure, you can use the keyword directory in the PRODUCT CODE CLASSIFICATION DATABASE. In most cases this database will identify the classification regulation in the CFR. You can also check the classification regulations below for information on various products and how they are regulated by CDRH.
Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical Mercury Thermometer. Once you find your device in the panel's beginning list, go to the section indicated: in this example, 21 CFR 880.2920 . It describes the device and says it is Class II. Similarly, in the Classification Database under "thermometer", you'll see several entries for various types of thermometers. The three letter product code, FLK in the database for Clinical Mercury Thermometer, is also the classification number which is used on the Medical Device Listing form.
Once you have identified the correct classification regulation go to: What are the Classification Panels below and click on the correct classification regulation or go to the CFR Search page. Some Class I devices are exempt from the premarket notification and/or parts of the good manufacturing practices regulations. Approximately 572 or 74% of the Class I devices are exempt from the premarket notification process. These exemptions are listed in the classification regulations of 21 CFR and also has been collected together in the Medical Device Exemptions document.