FDA Will Test Ability to Receive Digital Annotated ECG Waveform Files as Agency Prepares to Transition to New ECG Warehouse

Individuals can test the new system’s capability by submitting annotated ECG files

[12/10/2020] The U.S. Food and Drug Administration is now testing its capability to receive annotated electrocardiogram (aECG) waveform data in electronic format in accordance with the Health Level Seven (HL7) Annotated ECG Waveform Data Standard. Individuals who would like to voluntarily test this capability can submit the aECG files directly through the FDA electronic submissions gateway (ESG); they would also still need to upload ECG waveforms to the ECG Warehouse.

FDA expects that by March 2021, sponsors will submit their ECG data to the agency through the FDA ESG. These ECG data are typically collected to support the evaluation of drug-induced QT/QTc interval prolongation (ECG measurements to assess the heart’s electrical properties) and proarrhythmic (new or more frequent occurrences of an irregular heartbeat) potential as described in the International Council for Harmonisation (ICH) E14 guideline. Individuals with questions can contact the project manager in the appropriate CDER review division.

Please visit Interdisciplinary Review Team (IRT) for QT studies for more information about cardiac safety studies.