Medical device classification - FDA overview

\"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.\" - FDA

Info

• The overview is publicly available here: https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
• This page was last updated June 12th 2025

Other relevant documents

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff