Do I need to notify the FDA of Management Representative changes?

E

eas1229

#1
Hi

I am a new Management Rep for an IVD company. Do I need to notify the FDA of this change? I know what to do for ISO, but not sure for FDA. Any help would be appreciated.

Thanks!
 
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Doug Tropf

Quite Involved in Discussions
#2
Re: Management Rep

The FDA does not need to be notified, however your appointment should be documented in your company's QMS.
 
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