Reference page

Device classification

Every medical device sold in the United States belongs to one of three classes. The class is set by the risk the device presents, and it determines what a manufacturer must do before selling it. FDA has classified roughly 1,700 generic device types across 16 medical specialties. A device does not get classified individually. It is matched to a generic type that FDA has already classified, and it inherits that type's class.

FD&C Act 513(a)(1); 21 CFR 860; 21 CFR 862–892

At a glance

Class I	Lowest risk. General controls are enough. Around 74 percent of Class I devices are exempt from 510(k).
Class II	General controls are not enough, but special controls can provide reasonable assurance. Most devices requiring a 510(k) sit here.
Class III	Life-supporting, life-sustaining, of substantial importance in preventing impairment of health, or presenting a potential unreasonable risk. Usually requires a PMA.
What sets the class	The generic device type your device falls into, identified by its FDA product code.
Where to look it up	The FDA Product Classification Database. Free, public, searchable by device name or product code.
The law	Classes are defined in FD&C Act 513(a)(1) and 21 CFR 860.3. Individual devices are classified in 21 CFR 862 to 892.
If FDA has not classified it	It is automatically Class III by statute. A De Novo request or a PMA is required.
To get FDA's own view in writing	A 513(g) Request for Information. $8,596, or $4,298 as a small business, from 1 October 2026.

The three classes

The classes are not descriptions of how complicated a device is. They describe how much regulatory control is needed to give reasonable assurance that the device is safe and effective.

Class I

General controls alone are sufficient. General controls are the baseline requirements that apply to every device in every class: registration, listing, labeling, good manufacturing practice, adverse event reporting, and the prohibitions on adulteration and misbranding. Approximately 572 Class I device types, around 74 percent of them, are exempt from premarket notification.

Class II

General controls are not sufficient, but there is enough information to establish special controls that are. Special controls can include performance standards, postmarket surveillance, patient registries and FDA guidance documents. This is where most devices requiring a 510(k) sit.

Class III

There is not enough information to establish that general or special controls give reasonable assurance of safety and effectiveness, and the device is life-supporting, life-sustaining, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. Class III devices require premarket approval under section 515 of the FD&C Act. A small number of pre-1976 Class III devices still reach the market through a 510(k).

The product code carries the class

FDA assigns each generic device type a three-letter product code. The product code is tied to a classification regulation in 21 CFR Parts 862 to 892, and that regulation states the class.

A worked example. The clinical mercury thermometer has product code FLK and classification regulation 21 CFR 880.2920. Read that regulation and it states the device description and the class.

The class then determines the submission. Class I or II and not exempt means a 510(k). Class III usually means a PMA. Exempt means registration and listing only.

This is why the product code is the single most consequential field a manufacturer selects. No other entry carries the same consequence.

"Exempt" does not always mean exempt

An exemption from premarket notification is not unconditional. Every classification part carries a limitations section, numbered 8xx.9 — 21 CFR 862.9, 878.9, 888.9 and so on. The wording is identical in every part.

A manufacturer of an otherwise exempt Class I or II device must still submit a 510(k) when the device is intended for a use different from the intended use of a legally marketed device of that generic type, or when the device operates using a different fundamental scientific technology than a legally marketed device of that type. Additional limitations apply to certain in vitro diagnostic devices.

FDA gives its own example of a different fundamental technology: a surgical instrument that cuts tissue with a laser beam rather than with a sharpened metal blade.

A device can therefore sit under an exempt product code and still require a 510(k). Reading the product code without reading the 8xx.9 limitations is how companies reach the border believing they are exempt.

Questions people ask

How do I find my device's class?

Search the FDA Product Classification Database by device name or by product code. The record returns the class, the classification regulation, the review panel, and whether the device type is eligible for Third Party Review.

What if no product code matches our device?

A device type FDA has not classified is automatically Class III by statute. Two routes exist: a De Novo request, if general or special controls would give reasonable assurance of safety and effectiveness, or a PMA.

Can we ask FDA directly what class our device is?

Yes. A 513(g) Request for Information asks FDA for its view of the classification and the requirements that apply. FDA intends to respond within 60 days. The fee from 1 October 2026 is $8,596, or $4,298 for a qualified small business. FDA states that a 513(g) response does not constitute final agency action.

Does a Class I device need anything at all?

Yes. General controls apply to every class. Establishment registration, device listing, labeling requirements, quality system requirements where applicable, and adverse event reporting all apply to a Class I device, exempt or not.

Is the class the same in every country?

No. Classification systems differ between jurisdictions. A device that is Class II in the United States may be classified differently elsewhere, and an FDA class carries no authority outside the United States.