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# Class 2 for Retinal Diagnostic Software Devices
- URL: https://www.fdaweb.com/class-2-for-retinal-diagnostic-software-devices/
- Published: 2022-01-20T12:00:00.000Z
- Updated: 2026-09-14T17:29:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150963

*Federal Register* notice: FDA is classifying retinal diagnostic software devices into Class 2 (special controls). The action is in response to an IDx de novo classification request for its IDx-DR device. The agency has identified these as prescription software devices that incorporate an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-01147.pdf?ref=fdaweb.com).