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

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 878

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Food and Drug Administration has published 102 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This order is effective April 24, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2022-N-0794 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register