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# FDA Testing Annotated Electrocardiogram eSubmissions
- URL: https://www.fdaweb.com/fda-testing-annotated-electrocardiogram-esubmissions/
- Published: 2020-12-07T12:00:00.000Z
- Updated: 2026-09-14T16:39:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148238

FDA says it is testing its capability to receive annotated electrocardiogram (aECG) waveform data in electronic format under the [Health Level Seven](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f97KHcaOOQ7u-2FaCjWJGOMNseOmO8gEl6SYs-2FDXcI1vvll98MimjFL8CeBXKlTveebYHU3ufmS6atjXDwIIroZjnQWTXff-2BHyD987NXc-2FLBESFkw9vSkSCibMAsU-2FSMQOVfcUF4FQhCju24c-2FkvJn5aKa6IsjM3BPBbHxhBF84RRezSKs0j7z-2BLpC3KCrE1ypfKcFaD3EI9A18x4y1JGRDxsVesWNxOYZCXCAsx4-2BvH6HHLWgVA5whMmg5copm4l-2FMBaFlxsLH-2BmW22LJXNm8yleKiX792x3B66kXkRFKM4mouTgv8Yts2erh-2B8sNnefJ7JvQVarivH5MbfOQzzZU3plVPsVKn1ddWn6AtRKEa8l48I7roXZdbjWaZFHHtB29dIA-3D-3Dozln%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2B7Z9Ce1bT9lr9W7QxQt3lCrXPJKR46EYvc67iAJhJ79e-2BE3POVlKz8UY1GdZR8EvvBhyMgfRuVL-2BXpzwEJsB7Qcur9GYigxlxDBKfPLCoT8R-2FtRJbBkkCf8OCSHUEjrdAEy7PTN6iNfg5QWI-2BeqcF-2Fm3hO-2FfB4vehGqPelADCxtLItiQh6cWl5lu5qO2tgVr7t-2BA-2BfuE68UD85xNPYUi5WEqOwB00xeG0j-2BBW-2F-2FTLW-2FIn9Q674YvbgTgltcz5SvUM-3D&ref=fdaweb.com) (HL7) Annotated ECG Waveform Data Standard. Those who are interested in voluntarily testing this capability can submit the aECG files directly through the [FDA electronic submissions gateway](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f9wgMAtjLAQrGivegWKtTaBdi73g83EDm7rf5ZEqUt9SYJyzPPGDOjsmR46CptDfKppSGRCSjzkpL9I07maP8OWqzFpzIbuhY5sjLI9-2B8SGihd1b08WeXs3H2npK7wT1WMPv8bOHonsflWAe6Sq9I5dtmxbDtoAXZemVpWoOKtl5hPl5BeJI0YCs4o1VLy37F1n8Y-2FJ5XctnkI6C6XA81k6Ue-2BkJZxakiftTl6N3IIZkU0XtUjmcit7xhZemI5ah0-2FOPqGQYMwJ2ZIwRvPzrvDmC4Ygxvupto7b8rTVY8ESTUFBrEu4yATwX-2B72X6yAzJZqBTQOi8nwb-2Fe1RanK21J8eN8yrjPcI1Lao5-2Fnhb8Zc8J4j8qoMbt7-2FAhQ4-2FoFY1FkJ1PcOu22GI9oeo6lS1GvA-3Dyd7r%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2B7Z9Ce1bT9lr9W7QxQt3lCrXPJKR46EYvc67iAJhJ79e-2BE3POVlKz8UY1GdZR8EvvBhyMgfRuVL-2BXpzwEJsB7QQYzXDy94mXTxPd1jP5kW6f4clvr-2Funy527FxaUbGEvd4Vc6DOmcYHVq2ORTRPhCenUSNuSbKGL3HK3l6Evl5TBbjphaL-2FItoooIxTK4YbLwQwdLgExaRGLWp12b97pzRJS6V-2FOW72L3Zsgm-2BFc2LL2lM93R3yj3rImUm0dbr638-3D&ref=fdaweb.com) (ESG). The files submission would still need to uploaded to the [ECG Warehouse](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f973R7vJtoFQ73dqeKdq4yGLwA1FCts1mZyHoN8QrF36f12RrmKPK2OO-2FWOTJcavJU4-2B-2Bwz2fcYBsEi0iR0gG3bRftuN27NCE7vmEnn7rhKcVxNvkW3fv-2Fh7I22epjuh-2BMzn6Q2m-2B-2FmpSGh9nmiHkbn2GB8HsnX0r2oKDd6aH-2BWEopTfBz-2BmqtsQoyz50hsADloEFzXukgmr-2BqwboLsVifC0O48c-2BcKPriWHiJlTKyKPebdtt3GbcwEbdnW8cMn-2BIwv96XWG3qeJxMWhxms22wWK19rtYLN8U57t6g5HUPiQDbzWQIImQ5HNO27knsoDmh6QKSi7TPM-2B49YoSVdp1oieW0ZiRUxepe1BBEfwnoXGwXJSI%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2B7Z9Ce1bT9lr9W7QxQt3lCrXPJKR46EYvc67iAJhJ79e-2BE3POVlKz8UY1GdZR8EvvBhyMgfRuVL-2BXpzwEJsB7Q-2B6F7zsQhqmkjhxNSCBZiCySNgh1WsGYwwGIHHyXX5d-2FAQqyPUPs0aLxHbC3-2Bo7WHgWfOhgunaLjrENwkIkouSZEUU9PVuOtpXQvt2XVU4tOGB-2BR3s3ZfnrODG5NWdRIrBjBDYN5nB8Hi9drMmMcCcC8LYtLsWi81V-2BgBZSVnmHg-3D&ref=fdaweb.com), the agency says.

By March, FDA expects sponsors will submit their ECG data through the gateway. These ECG data are typically collected to support drug-induced QT/QTc interval prolongation and proarrhythmic (new or more frequent occurrences of an irregular heartbeat) potential evaluations described in the International Council for Harmonization (ICH) [E14 Guideline](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f9wpvZcFJkVjUp7Mhf5Nt-2Be1Ira8FsxOlt1pQs8EgtpRTpH-2FLquANM5x76S8A3Z-2Bxhe7lTKiBv99tl320XCZs1J4lppj-2FWXDx3sE7Wici2C6UenK90PVMpVYnDbbgh6-2FUQJ14Prjp0FYtBlJPPsBEqxHBRPeJW3inxh06XI7YAbqivzGHRydUAqP55KEh47fdFRLsfQKWKXKx6QsIhz5MUYH4AYXlpyF81Ux7-2Fb8TkWZgdRzio-2Bq1GwzVapEUWDMY-2FZAKQC1ggMOglKycgVv9ZHaWMhJfncxf6qw8wF-2BU3PsJGYYWB9lDpUMgXMkuTEvkPqhF4990MrYJm0kcsmpZ5PC84UVYDoabRJOm8rW1gqpQtSnH-2FPr-2Be1GcO-2BPXEeVTD8uX7KACuZEXdlk1Zjn0uV8JXetD6VloueqRYDeBBfkeL-rQ%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2B7Z9Ce1bT9lr9W7QxQt3lCrXPJKR46EYvc67iAJhJ79e-2BE3POVlKz8UY1GdZR8EvvBhyMgfRuVL-2BXpzwEJsB7QkjeH-2BvOc56615hpfksyGnZU9l2lf6N-2F5qSgHxu9Z9K3Y-2FFHhtqcOlbcH3EXKzvFdMAF-2BUFqLtwR9TImXDvNMt15wJhWle96XIGa4cGLY-2BSgmgxl-2B-2FWR3lEeF4DAdHjLaPIYQKRKEcziDCzNIyPD8A7fhxXghJWavI0IXTfY2cOo-3D&ref=fdaweb.com). More information is [available here](https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/interdisciplinary-review-team-cardiac-safety-studies-formerly-qt-irt?utm%5Fmedium=email&utm%5Fsource=govdelivery).