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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
The Food and Drug Administration (FDA) has
established classifications for approximately 1,700 different generic types of devices and
grouped them into 16 medical specialties referred to as panels. Each of these generic
types of devices is assigned to one of three regulatory classes based on the level of
control necessary to assure the safety and effectiveness of the device. The three classes
and the requirements which apply to them are:
Device Class and Regulatory Controls
The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.
Device classification depends on the intended use of the device and
also upon indications for use. For example, a scalpel's intended use
is to cut tissue. A subset of intended use arises when a more specialized indication
is added in the device's labeling such as, "for making incisions in the
cornea". Indications for use can be found in the device's labeling, but
may also be conveyed orally during sale of the product. A discussion of the
meaning of intended use is contained in Premarket
Notification Review Program K86-3.
In addition, classification is risk based, that is, the risk the device poses to the
patient and/or the user is a major factor in the class it is assigned. Class I includes
devices with the lowest risk and Class III includes those with the greatest risk.
As indicated above all classes of devices as subject to General Controls. General
Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that
apply to all medical devices, Class I, II, and III.
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, or 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 and the Precedent Correspondence 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.
Descriptions of each class of devices
Updated August 4, 2004
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