Module 18 2021

08/02/2021

Examples – multifaceted products Ophthalmics: Corneal collagen crosslinking..

PHOTREXA Viscous

PHOTREXA

KXL system

Device

Software

Drug UVA activated

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Example – regulatory management of a multifaceted product

Complex Class III Medical Device  Performs in situ treatment.

 Contains software that manages the treatment The drug component is licensed separately as a pharmaceutical and is administered via the device during treatment.  Drug component cannot be 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?

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