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
Key claim: The FDA is placing physician software that helps evaluate suspicious skin lesions for cancer into a moderate-risk (class II) category with special controls, which should make it easier for these tools to reach patients.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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 classification of the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
Routine FDA device classifications shape which diagnostic tools physicians can readily offer patients. Placing physician-use software for suspicious skin lesions into Class II with special controls replaces the more burdensome Class III premarket approval process with a 510(k) pathway, which typically speeds market entry for similar adjunctive diagnostic software.