Argus Safety - CDRH Revised Guidance in May 2020 for eMDR Submissions
(Doc ID 2712826.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.2 to 8.2.2 [Release 8.1 to 8.2]Information in this document applies to any platform.
14-Oct-20: added country ‘PALESTINIAN TERRITORY, OCCUPIED’
Goal
The purpose of this document is to provide a workaround for the latest regulation updates published in May 2020 by the Center for Devices and Radiological Health (CDRH).
Effective from May 2020, AS-2 submitters should not send ISO 3166 country codes, but are expected to send GENC3 codes.
These requirements are logged as an Argus enhancement request 31836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May202031836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May2020 31836633 - eMDR Regulation Updates May2020 .
Solution
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In this Document
| Goal |
| Solution |
| References |