Federal Register #2026-22179

FDA Class II classification and special controls for DermaSensor’s skin-lesion diagnostic device

The FDA issued a regulatory classification for DermaSensor’s skin-lesion diagnostic device; this is not a purchase solicitation. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - OEM/requester: DermaSensor Inc., identified as the requester for De Novo classification of its DermaSensor device. - Device: A prescription software-aided adjunctive diagnostic device that analyzes optical or other physical properties of a skin lesion and returns a classification. It is intended to provide physicians a second read after a suspicious lesion has been identified, not to diagnose on its own or confirm a clinical diagnosis. - Regulatory requirements: Classified as a Class II device subject to special controls covering clinical and non-clinical performance, accuracy across subgroups, compatible hardware, precision, electrical and other safety testing, reusable-component reprocessing, biocompatibility, software verification and validation, human factors, and labeling. Applicable premarket notification requirements remain in effect. - Procurement scope: No quantities, part numbers, requested services, or period of performance are specified.

Description

The FDA classifies the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer as a class II device subject to special controls. The prescription device analyzes optical or other physical properties of a skin lesion and returns a classification. It is intended as an adjunctive second-read tool for physicians following identification of a suspicious lesion, and is not intended for standalone diagnosis or to confirm a clinical diagnosis. The final order codifies the classification and identifies special controls covering clinical and non-clinical performance testing, safety, software, human factors, and labeling.

View original listing