The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Products hence require premarket approval unless FDA has enough data for re-classification into class I or class II, respectively.

On August 14, 2018, the manufacturer Apple Inc, requested for De Novo classification to FDA for the electrocardiograph software, ECG App, for Over-the-Counter use. Following 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 of the device has been coined as “electrocardiograph software for over-the-counter-use”, and it is identified as a device that creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias.

Table 1: FDA’s Identified Measures Required to Mitigate the Associated Risks to Health as follows:

Identified Risks

Mitigation Measures

Poor quality electrocardiograph (ECG) signal 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 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.

The new classification is added to PART 870—CARDIOVASCULAR DEVICES, 870.2345 to subpart C, and can be consulted for further information.


Medical Devices; Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use