Adverse Event Reporting Flowchart (US) - feedback appreciated!

Jen C

Involved In Discussions
We have been updating our event reporting SOP and have incorporated some new flowcharts into the drafts. I'd love to get some feedback/suggestions if anyone has any!

(I will copy this post in the US, Canada, and EU forums, but they will each have a different flowchart attached.) :tg:

Thanks,
Jen
 

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yodon

Leader
Super Moderator
Maybe I'm being overly-critical but the path out of "occurred outside of US --> device the same / essentially the same..." may be too easy an out. You may want to consider if the event COULD occur with your (US) device, irrespective of similarity.
 

Jen C

Involved In Discussions
Thanks yodon! I'm not sure if I'm understanding correctly. This path on the flowchart refers only to events taking place outside of the US. The wording comes directly from the draft MDR guidance (July 2013) - and yes, I know it's just a draft, but we feel it reflects current FDA thinking. I don't see ex-US events mentioned specifically in 21 CFR 803, but I could be missing it (does anyone know if it's there?).

The wording in the guidance is "FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the US - or a device similar to a device marketed by the manufacturer that has been cleared or approved in the US - and is also lawfully marketed in a foreign country". I don't think there's a requirement to consider whether the event could occur with ANY device you market in the US, just one that's essentially the same as the one with which the event occurred. The intention of the wording in the guidance (as I understand it) is just to cover the fact that there are often slight differences in device models between countries, and this doesn't exclude you from needing to report.
 

yodon

Leader
Super Moderator
I believe post-market vigilance is getting more scrutiny. If you become aware of an event that could occur with your device, you choose to take no action because the event occurred with another device outside the US, then the event does occur with your device, you will be in a pretty indefensible position, IMO.

Besides, as a device user, wouldn't you want the device manufacturer to take every precaution to keep you safe? :)
 
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