Skin Lesion Device Order Shows How FDA Moves a Device Type Out of Class III

The Food and Drug Administration published a final order on March 25 reclassifying two types of skin cancer assessment devices from Class III, which requires premarket approval, to Class II with special controls. The order covers optical diagnostic devices for melanoma detection, product code OYD, and electrical impedance spectrometers, product code ONV. It renames them "software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer," and takes effect April 24, 2026.

FDA said manufacturers of these devices may now submit a 510(k) premarket notification and obtain clearance instead of filing a PMA. The two devices behind the order are MelaFind, a multispectral imaging device approved in 2011, and Nevisense, which measures electrical impedance and was approved in 2017. Both are meant for use on lesions suspicious for skin cancer when a dermatologist wants more information in deciding whether to biopsy.

Why newer devices start in Class III

The order sets out the rule. Devices that were not sold before May 28, 1976, the date of the Medical Device Amendments, are automatically placed in Class III by section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act, without any rulemaking. They stay there, and need premarket approval, unless FDA reclassifies them into Class I or II, or finds a new device substantially equivalent to a predicate that does not require approval.

Section 513(f)(3) lets FDA reclassify such a device by administrative order, either on its own initiative or in response to a manufacturer's petition. The new class must have enough controls to provide reasonable assurance of safety and effectiveness. FDA must rely on "valid scientific evidence" that is generally publicly available, and the law lets it use clinical and preclinical data from an approved PMA six years after approval, though not trade secrets such as manufacturing methods. FDA acted on its own initiative here, after a proposed order in June 2022.

What the panel said, and what FDA did

FDA's General and Plastic Surgery Devices Panel discussed the proposal in July 2022. The order says some members thought enough information existed to set special controls, but "most Panel members disagreed," and several believed the device type should stay in Class III. Practical Dermatology reported at the time that the panel strongly recommended keeping the devices in Class III.

FDA went ahead, saying it had enough information from the MelaFind approval record, published literature and its adverse event and recall databases, and that the devices' adjunctive use, rather than standalone use, limits risk. It noted that the statute allows special controls to be set from just one device under the De Novo provisions. FDA added special controls in response to the panel, including clinical testing across age, body site and skin phototype; labeling that describes the population used to train the algorithm and its limits; postmarket surveillance data unless FDA decides they are not needed; and a sensitivity requirement of more than 90 percent for lesions with high metastatic potential, or a clinically justified alternative.

The order also limits what can be cleared. MelaFind and Nevisense have fixed algorithms, and FDA said a device with an algorithm that changes over time would very likely raise different questions of safety and effectiveness, which would rule out a finding of substantial equivalence. A future device that raises different questions would not fall within the Class II type.