FDA reclassification of two melanoma assessment device types
A 2026 final order changes the pathway for specified adjunctive devices while retaining special controls.
What changed
FDA’s final order, published on 25 March 2026 and effective 24 April 2026, moved optical diagnostic devices for melanoma and electrical impedance spectrometers from class III to class II with special controls. The order identifies device types associated with product codes OYD and ONV and subjects them to premarket notification.
The scope matters
These are adjunctive devices used in clinical assessment. The order does not create a general pathway for every skin-analysis app, consumer imaging tool or autonomous diagnostic system. Its clinical-performance and labeling controls must be read with each device definition and intended use.
From classification to an evidence plan
The practical question is whether a proposed product fits a specified classification, then what evidence supports that intended use. Our editorial suggestion is to document the target users, patients, output and role in the care pathway before translating a classification decision into study requirements. A different intended use may require a different assessment.
Sources & further reading
Read the original company post on LinkedInFederal Register — final FDA order, 91 FR 14445Adapted from a public company post, with sources checked on 8 October 2026. Original post dates are preserved; the website summary is not attributed to an individual employee.
