How many reports are required for testing?
The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems. Testing will continue until all issues are resolved satisfactorily. Issues can arise as a result of improper formatting, validation failures, etc. Below are six types of reports that are requested for testing. If a particular report does not apply to your situation, please discuss with an eMDR team member. • Initial 3500A • Initial 3500A with an attachment • Initial 3500A followed by a supplemental 3500A (supplemental to be submitted after initial is loaded successfully) • Initial 3500A with section F filled out (section F is used to provide information from user facility or importer source report) • Initial 3500A and source report(s) If you would like to submit additional report scenarios as a test, please contact an eMDR team member at eMDR@fda.hhs.gov.
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