Updates to the FDA's Electronic Medical Device Reporting (eMDR) System The U.S. Food and Drug Administration (FDA) has updated some event codes, terms, and definitions used in the adverse event Electronic Medical Device Reporting (eMDR) system to harmonize with the International Medical Device Regulators Forum (IMDRF) Adverse Event Reporting Terminologies. This update follows the FDA's announcement from May 2020 about including adverse event codes to reflect IMDRF terminology. Specifically, the FDA updated the Adverse Event codes accepted in sections F10 and H6 of the 3500A form to align with IMDRF. The eMDR system still accepts the corresponding FDA and National Cancer Institute Thesaurus (NCIt) codes. The eMDR system will no longer accept MDR submissions containing codes retired during this update. The eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG) should update their systems as soon as possible to match. In addition to the updates described above, the FDA has incorporated the 2021 IMDRF maintenance updates in the eMDR system. Note that, unlike the previously-announced update to harmonize sections F10 and H6 of the 3500A form with IMDRF, no codes were retired as part of this maintenance update, so there is no risk of MDR rejection as a result of this maintenance update. For details on the specific changes in the IMDRF maintenance updates, see the Coding Resources page. Questions? If you have questions, contact the Division of Industry and Consumer Education. | 
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