General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer
fda-device · Food and Drug Administration · Rule · Published 2026-03-25 · Effective 2026-04-24 · 91 FR 14445
Document
Document number
2026-05772
Federal Register citation
91 FR 14445
CFR reference
21 CFR 878
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2026-03-25
Effective date
2026-04-24
HHS docket
Docket No. FDA-2022-N-0794
Abstract
The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named "software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer." FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices.