The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls) effective October 30, 2026. According to the FDA, this classification will provide a reasonable assurance of the safety and effectiveness of the device. The full text of the order can be found in the Federal Register document.

Press Release: Food and Drug Administration

Published October 30, 2026. Reproduced in full from the Food and Drug Administration.

Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer

Action: Final amendment; final order.

Summary

The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key dates

  • Takes effect: October 30, 2026

This order is effective October 30, 2026. The classification was applicable on January 12, 2024.

Full text: Federal Register document 2026-22179