United States · Final order
FDA classification of software-aided adjunctive skin cancer diagnostic devices
FDA codifies class II classification and special controls for software-aided adjunctive diagnostic devices used by physicians on lesions suspicious for skin cancer.
About this rule
The final order adds the device classification to 21 CFR Part 878. The order is effective October 30, 2026, while the classification was applicable January 12, 2024. It establishes special controls for this device type; it is not a new clearance for every skin-analysis product. The official order contains the performance and testing requirements manufacturers must address.
- Agency
- Food and Drug Administration
- Instrument
- 21 CFR 878.1830; Federal Register 2026-22179
- Published
- Oct 30, 2026
- Effective
- Oct 30, 2026
Who it affects
Manufacturers of software-aided adjunctive diagnostic devices for physicians evaluating lesions suspicious for skin cancer.