Under 21 CFR 803.12 of the eMDR Final Rule, manufacturers and importers must submit supplemental or follow-up reports to FDA in an electronic format that FDA can process, review and archive. User facilities may submit follow-up reports to FDA in an electronic format, but are still allowed to report only on paper in accordance with 21 CFR 803.12(b).
The options for preparing and transmitting a supplement or follow-up report are the same as those for initial reports, discussed above. For all updates, you should include the initial report number and state that the type of submission is a follow-up report. Limit your additional entries to those where you need to update previously provided information. For example, if patient age and sex are unchanged, do not include them in your supplement or follow-up report. If you are updating or correcting the model number, provide the corrected information only. A submitter should use electronic submissions for supplemental or follow-up reports even for MDRs that were initially filed on paper.
