FDA classifies medical devices into Class I, II, or III under section 513 of the Federal Food, Drug, and Cosmetic Act, with the classes defined at 21 CFR 860.3, based on the risk the device presents and how much regulatory control is needed to provide reasonable assurance of safety and effectiveness. Class I relies on general controls alone, Class II adds special controls and typically a 510(k), and Class III requires premarket approval (PMA).
FDA has classified over 1,700 distinct types of devices across 16 medical specialty panels, codified in 21 CFR Parts 862 through 892. A device's class is tied to its specific product code and intended use, not to the device category in general. Two devices that look similar can sit in different classes if their intended use or risk profile differs.
The Three Classes Compared
| Class | Risk level | Controls | Typical pathway | Learn more |
|---|---|---|---|---|
| Class I | Low | General controls only (most are also exempt from premarket notification) | Registration & listing; many are 510(k)-exempt | Class I medical devices → |
| Class II | Moderate | General controls plus special controls (e.g. performance standards, postmarket surveillance) | 510(k) premarket notification | Class II medical devices → |
| Class III | High | General controls and premarket approval | Premarket Approval (PMA) | Class III medical devices → |
How to Find a Device's Class
Classification is determined by matching the device's intended use and technological characteristics to an existing classification regulation in 21 CFR Parts 862 through 892, which is normally expressed through its FDA product code. FDA's product classification database is the starting point for this comparison. When the classification genuinely is not clear from the database and no comparable predicate settles the question, FDA's 513(g) Request for Information is the formal way to obtain the agency's written views on a device's classification and the requirements that apply.
Not Sure What Class Your Device Falls Into?
ADB's regulatory team issues a written Classification Determination Memo covering product code, device class, and regulation number, with rationale.
See 513(g) & Classification Book a Free ConsultFrequently Asked Questions
What are the three FDA medical device classes?
Class I, Class II, and Class III, defined at 21 CFR 860.3. Class I carries the lowest risk and general controls only; Class II carries moderate risk and typically needs special controls plus a 510(k); Class III carries the highest risk and needs premarket approval (PMA).
How many device types has FDA classified?
FDA has classified over 1,700 distinct types of devices, organized across 16 medical specialty panels and codified in 21 CFR Parts 862 through 892.
How do I find out what class my device is?
Identify the device's product code and matching classification regulation, usually by comparing your device's intended use and technology to FDA's existing classification database. If the classification is genuinely unclear, FDA's 513(g) Request for Information is the formal way to obtain the agency's written views.
Can a device move between classes?
Yes. FDA can reclassify a device type by administrative order under section 513(e) of the FD&C Act, on its own initiative or in response to a petition, when new information shows that a different level of regulatory control is appropriate. Reclassification does not happen automatically.