Versions Compared

Old Version 18

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version 19

changes.mady.by.user Kathleen Mellars

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger.  The sponsor did not collect device events for the heatstick used in the System Holder and Chargerthe operation of the electronic cigarette device. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. TEDCODE was the Level 3 IMDRF term. 

...