2026-22179·DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Final RuleEffective

Published: Oct 30, 2026
Effective: Oct 30, 2026
Citation: 91 FR 68465
Docket: Docket No. FDA-2026-N-12213
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has re‑classified a “software‑aided adjunctive diagnostic device” that doctors use to examine skin lesions that may be cancerous. By placing the device in Class II, the agency is applying specific “special controls”—such as performance standards, labeling requirements, and post‑market monitoring—to ensure the device is safe and works as intended while still allowing quicker market entry for innovative tools. The rule was issued by the U.S. Department of Health and Human Services, through the FDA, and it affects manufacturers of these diagnostic devices, the physicians who use them, and ultimately patients seeking skin‑cancer screening. The classification change is intended to give patients faster access to useful technology while maintaining appropriate safety oversight. The regulation was published in the Federal Register on October 30, 2026 (91 FR 68465) and took effect the same day. Because this is a final rule, there is no additional public comment period; the FDA will now incorporate the special controls into the Code of Federal Regulations and enforce them for any new or existing devices of this type. Manufacturers will need to comply with the specified controls before marketing the devices, and the FDA will continue to monitor compliance and device performance.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.