Provision Consulting Group

FDA, Classify Your Medical Device

December 29 2022

There are a number of pathways available to bring a medical device to market. The regulatory pathway for a specific device depends on the classification of the device, which is based on risk as well as the level of control necessary to mitigate such risks to health.

Medical devices are categorized into one of three classes based on their degree of risk.

The class to which your device is assigned determines, among other things, the type of premarket submission necessary, if required, to legally market your device.

Medical Device Classification:

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.

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.

Premarket Approval (PMA) – Most Class III (high risk) devices require Premarket Approval (PMA) before they may be legally marketed. This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).
Premarket Notification 510(k) – Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketed.
De Novo – De Novo provides a possible route to classify novel devices of low to moderate risk.
Humanitarian Device Exemption (HDE) provides is a possible route to market medical devices that may help people with a rare diseases or conditions.

Is your product intended for General Wellness?

If your product is intended for general wellness use only, and is low risk, it may not be actively regulated by the FDA.

Does your product include drugs or biologics?

Combination products are therapeutic and diagnostic products which combine drugs, devices and biological products.

How will FDA determine an accessory’s classification?

FDA intends to determine the risk of accessories and the controls necessary to reasonably assure their safety and effectiveness in the same way used for any other device classification. In determining the classification of an accessory, the FDA will evaluate the risks posed by the accessory’s impact on the parent device and any unique risks of the accessory independent of its parent device. As with the classification of any other device, the types of regulatory controls necessary to control the risks will determine the regulatory class for accessories.