UDI IVD - before submission?

mflick22

Registered
Do you need a UDI before you submit your PMA to the FDA? Our company is about 2 months out from submitting our PMA submission and were not sure if our final labeling needs the UDI on it before or we can apply for it after? Any feedback would be great. thank you
 

yodon

Leader
Super Moderator
I don't think so. In all the submissions I've been around, the labeling just shows a placeholder for the UDI (barcode + text). Wouldn't be a bad idea, though, to go ahead and register and get everything set up (up to entering in GUDID).
 

mflick22

Registered
Thank you, I was thinking the same thing. I went from working at a billion dollar company where my regulatory role was very specific (as we have like 30 regulatory people) to a small startup, so now I'm in charge of things that I haven't done sine 2013. Therefore I know a lot has changed in the regulatory areas I wasn't involved in day to day.
 
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