FDA considers the receipt date for an eMDR to be the date the eMDR arrived at the ESG (Acknowledgment 1), but only if the eMDR is successfully loaded in the CDRH database (a passing Acknowledgment 3). If a failure occurs during the validation or loading process, the error is described in Acknowledgment 3. The reporting entity should correct the error(s) and resubmit the eMDR. If the resubmitted eMDR is successfully loaded, (a passing Acknowledgment 3), the receipt date will be the date that the resubmitted eMDR arrived at the ESG, as documented in the Acknowledgment 1 issued for the resubmitted eMDR.
The time zone should not be a concern for timely reporting under MDR. Although Acknowledgment 1 displays both the date and time according to the Eastern Standard Time (EST)/Eastern Daylight Time (EDT) zone, MDR considers only the date for the purposes of calculating timely reporting. If the report is successfully loaded, this processing should take no more than an hour. Although Acknowledgment 1 displays EST/EDT, FDA will consider the local time of the submitter when determining the submission date, just as a postmark date is used for mailed paper reports.
