FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GENERAL AND PLASTIC SURGERY DEVICES; CLASSIFICATION OF THE SOFTWARE-AIDED ADJUNCTIVE DIAGNOSTIC DEVICE FOR USE BY PHYSICIANS ON LESIONS SUSPICIOUS FOR SKIN CANCER

WASHINGTON, Oct. 30 -- Food and Drug Administration has issued a rule called: Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer.

The rule was published in the Federal Register on Oct. 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classifi...