In this article, you will learn what is the Medical Device Classification and Classification Panels as per the Food, Drug, and Cosmetic Act (FD&C Act) and which considerations involve in terms of regulatory requirements.
A medical device is a product, such as an instrument, machine, implant, or in vitro reagent, that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions. Read more information about what is a medical device according to the FD&C Act.
Search the Product Classification Database
Search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:
At this moment, the Food and Drug Administration (FDA) has defined classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.
What are the Medical Devices Classification Panels
Typically, the medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892.
In addition, the FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty “panels” such as Cardiovascular devices or Ear, Nose, and Throat Devices.
These panels are found in Parts 862 through 892 in the CFR.
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. Your device should meet the definition in a classification regulation contained in 21 CFR 862-892.
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 (3) THREE MEDICAL DEVICES CLASSIFICATIONS OR CLASSES:
1. Class I General Controls
2. Class II General Controls and Special Controls
3. Class III General Controls and Premarket Approval
MEDICAL DEVICES REQUIREMENTS BASED ON ITS CLASS.
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.
Otherwise, a 510k will be the route to the market if 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.
For further information on how to classify a medical device, please refer to the Classify Your Device page.
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