The automatic assignment of class III occurs by operation of law and without any action by the FDA, regardless of the level of risk posed by the new device. Products hence require premarket approval unless the FDA has enough data for re-classification into class I or class II, respectively.
On August 14, 2018, the manufacturer Apple Inc requested De Novo classification from the FDA for the electrocardiograph software, ECG App, for Over-the-Counter use. Following the FDA's review, it was determined that the device can be classified into class II with the establishment of special controls. These added special controls shall assist in granting reasonable assurance of the safety and effectiveness of the ECG App. The generic type of the name has been coined as "trocardiograph software for over-the-counter use", and it is identified as a device that creates a device, displays electrocardio data, and can provide information for identifying cardiac arrhythmias.
FDA's Identified Measures Required to Mitigate the Associated Risks to Health:
| Identified Risks | Mitigation Measures |
|---|---|
| Poor quality electrocardiograph (ECG) sign resulting in failure to detect arrhythmia | Clinical performance testing, Human factors testing, and Labeling. |
| Misinterpretation and/or over-reliance on Device output, leading to: - Failure to seek treatment despite acute symptoms. - Discontinuing or modifying treatment for a chronic heart condition. | Human factors testing, and Labeling. |
| False-negative resulting in failure to identify arrhythmia and delay of further evaluation or treatment | Clinical performance testing, Software verification, validation, and hazard analysis; Non-clinical performance testing; and Labeling. |
| False positive resulting in additional unnecessary medical procedures. | Clinical performance testing; Software verification, validation, and hazard analysis; Non-clinical performance testing; and Labeling. |