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# FDA Pediatric ECG Warehouse Helps Product Development
- URL: https://www.fdaweb.com/fda-pediatric-ecg-warehouse-helps-product-development/
- Published: 2021-08-18T12:00:00.000Z
- Updated: 2026-09-14T17:11:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149958

Building on the success of its electrocardiogram (ECG) data warehouse that supports FDA’s cardiac safety review of therapeutic product development programs, the agency has created a first-of-its-kind pediatric ECG data warehouse. The warehoused ECGs will be analyzed in pediatric product development programs to help prevent sudden cardiac death in the young (SCDY).

An agency online [post](https://www.fda.gov/drugs/news-events-human-drugs/first-kind-pediatric-ecg-data-warehouse-use-pediatric-product-development-programs-and-prevention?ref=fdaweb.com) says FDA staff partnered with Duke University and multiple medical industry members to secure ECGs from public screening groups (primarily parent-led foundations).

Due to the variability of methods and the ranges of data obtained by the study groups, the warehouse staff developed a core set of essential data elements to promote uniform practices. They also created a universal scannable form, in electronic and paper format, to enable direct digital transfer to the data warehouse through software processing of form images.

Study groups have provided almost 40,000 ECGs to the pediatric warehouse to date, the post says. FDA says the warehouse “promises significant public health advances, including the elaboration of clinical guidelines for assessing risk in children, including risk for SCDY; better pre- and post-market cardiac safety evaluation in children; and the development of biomarkers for use in pediatric clinical trials.”