Original article title
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
Takeaway
FDA codified a class II category with special controls for software-assisted assessment of suspicious skin lesions. The order formalizes a classification applicable since January 2024, rather than announcing a new replacement for physician diagnosis.
Keep in mind
Final device-classification order.
www.federalregister.gov
The takeaway was checked against source text. The original title is preserved above.
This is a reading aid. Follow the source for methods, limitations, corrections, and clinical context.