Data / Federal rules / 2026-05772
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
The Food and Drug Administration published this final rule in the Federal Register on March 25, 2026. It took effect on April 24, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-05772
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 25, 2026
- Takes effect
- April 24, 2026
- Dates
- This order is effective April 24, 2026.
- Docket
- Docket No. FDA-2022-N-0794
- Code of Federal Regulations
- 21 CFR 878
- Topics
- Medical devices
- Pages
- 14
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in March 2026
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.