Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Example 2 – regulatory management of a multifaceted product

Complex Class III Medical Device  Makes the biopharmaceutical (e.g. targeted DNA/RNA)  Performs in situ treatment.  Contains software that manages the treatment The drug component is licensed separately as a biopharmaceutical and is administered via the device during treatment.  Drug component cannot be made/used without the device

What would be involved if a regulatory agency identified an issue based on adverse event feedback from using the device, and requests a change to the labelling?

The Organisation for Professionals in Regulatory Affairs

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tslimx2 + Dexcom G6

The Organisation for Professionals in Regulatory Affairs

26

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