Module 15 2022

19/05/2022

Summary

• The manufacturer is still expected to collect clinical data on the actual device, but if the equivalency argument is accepted this can be done post-market • Equivalency works well for those devices that are a modification of an existing device already marketed by the same manufacturer • The more complex the device, the harder it is to claim equivalency • High-level equivalency does not translate to low-level equivalency (remember, both are fish!) • If equivalency cannot be claimed the device can be claimed to be similar and the data leveraged for state-of-the-art and identifying safety and performance criteria

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

39

Summary

So are they equivalent?

•

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

40

20