# 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
> **Food and Drug Administration** · Final amendment; final order. · Published 2026-03-25 · Effective 2026-04-24 · 91 FR 14445
## Document
- **Document number:** 2026-05772
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 91 FR 14445
- **CFR reference:** 21 CFR 878
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma)
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