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Product safetyFDAUnited StatesImports

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

30 October 2026

In plain English

FDA classifies the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II with special controls.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
30 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 determ
The full text is at the source

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