FOOD AND DRUG ADMINISTRATION ISSUES RULE: GENERAL AND PLASTIC SURGERY DEVICES; RECLASSIFICATION OF OPTICAL DIAGNOSTIC DEVICES FOR MELANOMA DETECTION AND ELECTRICAL IMPEDANCE SPECTROMETERS, TO BE RENAMED SOFTWARE-AIDED ADJUNCTIVE DIAGNOSTIC DEVICES FOR USE ON SKIN LESIONS BY PHYSICIANS TRAINED IN THE DIAGNOSIS AND MANAGEMENT OF SKIN CANCER

WASHINGTON, March 25 -- Food and Drug Administration has issued a rule called: General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer.

The rule was published in the Federal Register on March 25 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), bot...