The 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 does not achieve its primary intended purposes through chemical action

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 Exemptions
    - Without Exemptions
2. Class II General Controls and Special Controls
    - With Exemptions
    - Without Exemptions
3. Class III General Controls and Premarket Approval

Regulatory Pathways

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 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification 510(k).

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.

Class I General Control

A vast majority of Class I medical devices that is determined to be exempt, it only needs to comply with a minimum set of FDA requirements call general requirements. Most Class I devices take this pathway. However, exempt devices are not subject to Design Control Regulations of the Quality System Regulations, unless specified. These requirements oblige the company to:

• register their facility or establishment with the FDA
• fill out a form listing the device and its classification
• comply with general FDA labeling and packaging requirements
• Good Manufacturing Practice (GMPs)
• establish a repair, replacement, and refund procedure
• adhere to FDA’s Quality System regulations

Action: Class I & II Medical Device Exemptions

Approximately 75% 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.

Class II General Control plus Special Control

Class II medical devices are subject to both general control plus special controls. The majority of class II devices requires premarket notification, or 510(k), to show that they are substantially equivalent to an existing “predicate” device. The additional special requirements oblige the company to:

• fulfill performance standards (i.e ISO, ANSI, ASTM, ASA)
• device tracking (GUDID)
• guidance documents
• patient registry
• majority of class II devices requires 510(k) submission

Class III General Control plus Premarket Authorization (PMA)

Class III medical devices are subject to both general control plus special controls. The majority of class II devices requires premarket notification, or 510(k), to show that they are substantially equivalent to an existing “predicate” device. The additional special requirements oblige the company to:

• fulfill performance standards (i.e ISO, ANSI, ASTM, ASA)
• device tracking (GUDID)
• guidance documents
• patient registry
• majority of class II devices requires 510(k) submission

How to Determine Your Classification

In order to find the medical device classification, and whether any exemptions exist, you need to find the regulation number that is the classification regulation for your device.

There are two methods for accomplishing this: either directly search the classification database for a device name, or, find your classification based on the medical specialty to which your device belongs using the device classification panel.

Approach 1: Using the product code classification database

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.

Action: Search in the Product Code Classification Database.

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.

Approach 2: Search by Medical Specialties

FDA has classifield each medical devices into 16 different medical specialties. Once you have identified the medical specialty, select the corresponding "Regulation Citation" and you will see a table listing a variety of different medical devices commonly used by the medical specialty.

Action: Locate classification using the Device Classification Panels

What's Next

The next step depends on the regulatory pathway for your product.

Action:

Navigating the 510(k) Process

Navigating the PMA Process

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