General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD and ONV, respectively), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "computer-aided devices which provide adjunctive diagnostic information about lesions suspicious for melanoma," along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. If finalized, this order will reclassify these devices from class III to class II and the submission of a premarket approval application (PMA) for these devices will no longer be required, and instead the submission of a premarket notification (510(k)) will be required.