Federal Register #2026-05772

FDA Reclassifies Melanoma Diagnostic Devices and Sets New Regulatory Controls

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final order impacting manufacturers of optical diagnostic devices for melanoma detection and electrical impedance spectrometers: - Devices affected: - Optical diagnostic devices for melanoma detection (product code OYD) - Electrical impedance spectrometers (product code ONV) - Now renamed and codified as 'software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer' - Regulatory changes: - Devices reclassified from Class III (high risk) to Class II (moderate risk) - Subject to special controls and premarket notification (510(k)), replacing the previous PMA approval requirement - Key requirements for manufacturers: - Clinical and non-clinical testing, including demonstration of at least 90% sensitivity for lesions with high metastatic potential - Labeling and performance measures such as sensitivity and specificity - Tailored study designs considering patient demographics and lesion types - Oversight of device modifications, especially those involving artificial intelligence or machine learning algorithms - Post-market surveillance and user qualification requirements - Notable devices referenced include MelaFind and Nevisense - No specific OEMs or vendors are named, but the regulation applies to all manufacturers of these device types - Place of regulatory activity: FDA Center for Devices and Radiological Health, Silver Spring, MD

Description

The FDA has issued a final order reclassifying optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II with special controls, requiring premarket notification. These devices are renamed as software-aided adjunctive diagnostic devices for use on skin lesions by trained physicians. The reclassification aims to provide reasonable assurance of safety and effectiveness while establishing special controls and regulatory oversight appropriate for these devices.

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