I have not seen anything from FDA to update their December 2020 announcement that you would be able to submit the annotated ECG data through ESG by March 2021.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 07-Apr-2021 12:26
From: GOUTHAM REDDY KANCHARLA
Subject: Annotated ECG through FDA ESG
Hi,
Can you please comment if there is any FDA guidance document available on the transmission of annotated ecg data through ESG?
Much appreciated if you can share your experience of dispatching ECG data through ESG.
Thank you.
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GOUTHAM REDDY KANCHARLA
Gaithersburg MD
United States
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