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# Class 2 for OTC Electrocardiograph Software
- URL: https://www.fdaweb.com/class-2-for-otc-electrocardiograph-software/
- Published: 2022-01-14T12:00:00.000Z
- Updated: 2026-09-14T17:28:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150936

*Federal Register* notice: FDA is classifying electrocardiograph software for over-the-counter use into medical device Class 2 (special controls). The action is based on an Apple Inc. request for de novo classification of its ECG App. The device is identified as one that creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiacarrhythmias. The agency notes that the device is not intended to provide a diagnosis. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-00827.pdf?ref=fdaweb.com).