FDA is committed to providing industry with adequate notice of any specification changes and, when possible, will ensure previous versions of such specifications can still be utilized to submit adverse events electronically. We will utilize our websites for MDR, eMDR, and FDA ESG as well as Federal Register notices and updates to this guidance (when appropriate) to provide sufficient advance notification of changes to all stakeholders. We will work with stakeholders on implementation of the changes and expect to support previous specifications long enough to ensure that HL7 and eSubmitter users are able to make the necessary changes.
