FDA device classes explained: Class I, II, and III

The FDA sorts every medical device into one of three classes based on the risk it poses to patients. The class determines how much regulatory control a device needs — and which market pathway it takes.

Class I — low risk

Simple, low-risk devices: bandages, examination gloves, most hand-held instruments. The majority are subject only to general controls (registration, labeling, good manufacturing practices), and many are exempt from premarket review entirely.

Class II — moderate risk

Devices where general controls aren't enough to assure safety, so they also carry special controls (performance standards, labeling requirements, post-market surveillance). Examples include infusion pumps, powered wheelchairs, and many diagnostic devices. Most reach market via a 510(k) clearance.

Class III — high risk

Devices that support or sustain life, are implanted, or present a potential unreasonable risk of illness or injury — pacemakers, implantable defibrillators, heart valves. These generally require the most rigorous pathway, a PMA approval backed by clinical evidence.

How class connects to everything else

A device's class is recorded against its product code, so it travels with the device across FDA datasets. On a device-type page you'll see the class alongside the device count, recalls, and adverse-event totals for that category — useful context when a high volume of reports appears on a Class III implant versus a Class I accessory.

Need device class in your data pipeline? It's included on every device and product-code response. Get a free API key or read the docs.