Medical Device Classification

FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes

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

1. Class I General Controls with and without Exemptions

2. Class II General Controls and Special Controls with and without Exemptions

3. Class III General Controls and Premarket Approval

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 exempted, a 510(k) will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Device classification depends on the intended use of the device and also upon indications for use. Indications for use can be found in the device’s labeling, but may also be conveyed orally during sale of the product. 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. In some circumstances devices are unclassified.

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: going directly to the classification database and searching for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, going directly to the listing for that panel and identifying your device and the corresponding regulation. Another way to find the classification of the device is searching in the product code classification database. You may also find the classification from the FDA, by submitting a 513(g) Request.

Liberty Management Group helps medical device manufacturers to register with US FDA and gives you access to a group of 510k consultants who assist in preparing your Traditional, Abbreviated, or Special 510k submission to the FDA. LMG also helps with ISO certification.

Written by:  Sonia Suresh, Junior Officer (FDA Regulations)