Zdrowie i gospodarka · 25/03/2026
FDA Reclassifies Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers
The FDA is reclassifying optical diagnostic devices for melanoma detection and electrical impedance spectrometers into class II, subject to premarket notification, and renaming them as software-aided adjunctive diagnostic devices for use on skin lesions by trained physicians.
Source: Federal Register — Food and Drug AdministrationOpen original release →