How Classification Works
FDA classifies medical devices into three classes — Class I, II, and III — based on the level of control necessary to provide reasonable assurance of safety and effectiveness. The system is codified in 21 CFR Parts 862–892.
The classification framework
Classification is established by regulation, not by FDA on a device-by-device basis. When FDA reviews a device type, it assigns a classification that applies to all devices within that type. Each classified device type has:
- A product code (three-letter alphanumeric, e.g., "FPA" for glucose meters)
- A device class (I, II, or III)
- An assigned review panel (one of 18 advisory panels)
- A reference to the applicable 21 CFR Part (e.g., 21 CFR Part 880 for general hospital devices)
- A regulatory requirement (exempt, 510(k), De Novo, or PMA)
How a new device gets classified
Pathway 1 — Find an existing classification
The majority of devices have an existing classification. Search the FDA Product Classification Database using device name, product code, or 21 CFR reference.
Pathway 2 — 510(k) clearance establishes equivalence
Submitting a 510(k) to a predicate device of known classification gives your device the same class as the predicate (typically Class II).
Pathway 3 — De Novo request
If no predicate exists but the device is low-to-moderate risk, a De Novo request creates a new device type with its own product code, classification, and special controls.
Pathway 4 — PMA for Class III
Class III devices require individual Premarket Approval demonstrating safety and effectiveness through valid scientific evidence.
Classification and review panels
FDA uses 18 expert advisory panels, each corresponding to a medical specialty. The panel is identified by the relevant 21 CFR Part:
| 21 CFR Part | Panel / Device Type |
|---|---|
| 862 | Clinical chemistry & toxicology (IVDs) |
| 864 | Hematology & pathology (IVDs) |
| 866 | Immunology & microbiology (IVDs) |
| 868 | Anesthesiology |
| 870 | Cardiovascular |
| 872 | Dental |
| 874 | Ear, nose, throat |
| 876 | Gastroenterology & urology |
| 878 | General & plastic surgery |
| 880 | General hospital & personal use |
| 882 | Neurology |
| 884 | Obstetrics & gynecology |
| 886 | Ophthalmic |
| 888 | Orthopaedic |
| 890 | Physical medicine |
| 892 | Radiology |
Searching for a classification
- Go to FDA Product Classification Database
- Search by device name, product code, or 21 CFR reference
- Review the product code entry for class, panel, submission type, and exemption status
- Cross-reference the 21 CFR section for the full classification regulation
Official resources
- FDA Product Classification Database
- 21 CFR Parts 862–892 — Device Classifications
- FDA — Classify Your Medical Device
Class I devices present minimal risk and require only general controls such as labeling, manufacturing standards, and proper device identification. Class II devices present moderate risk and require special controls in addition to general controls; these special controls may include performance standards, premarket testing, or post-market surveillance requirements. Class III devices present the highest risk and require Premarket Approval (PMA), which demands clinical evidence demonstrating safety and effectiveness through valid scientific evidence.