How do we submit the adverse event information from the initial reporter, such as a User Facility (U/F) importer or voluntary reporter?
Depending on the source of the initial report, you may submit the source report information as follows: • User facility or importer report – Include report information by populating the appropriate fields of the 3500A using CeSub (i.e., populate all sections of the message pertaining to MedWatch 3500A Section F). • Voluntary report – Submit this as an attachment to your electronic MDR. If you have more than one source report for the event—that is, both (1) and (2) as described above—include one report as part of your electronic MDR, and submit the other(s) as attachment(s).
