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Criteria for Reportable Event vs. Adverse Event in Device Studies - Page 2

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adverse event reporting, mdr (medical device regulations), mdr (medical device reporting), reportable event reporting (medical devices), medical devices
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  Post Number #9  
Old 6th July 2010, 03:51 PM
dblnkl

 
 
Total Posts: 37
Re: Criteria for Reportable Event vs. Adverse Event in Device Studies

Hmmm, since there is only one line here, I can only say that I have to read "between the words" a bit. If the product "has not recieve (sic) marketing approval from the FDA," then I assume either that it must still be in a clinical trial or that the trial was completed and the application for marketing approval filed but denied. In NEITHER case would MDR reporting be appropriate. In fact, this is something to be thankful about: MDR reports are public; NOT having to file public AEs/SAEs during a clinical trial might save us some embarrassment.

Last edited by dblnkl; 6th July 2010 at 08:35 PM. Reason: clarification

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  Post Number #10  
Old 16th March 2018, 05:39 PM
IZAKK

 
 
Total Posts: 4
Re: Criteria for Reportable Event vs. Adverse Event in Device Studies

Quote:
In Reply to Parent Post by dblnkl View Post

Hmmm, since there is only one line here, I can only say that I have to read "between the words" a bit. If the product "has not recieve (sic) marketing approval from the FDA," then I assume either that it must still be in a clinical trial or that the trial was completed and the application for marketing approval filed but denied. In NEITHER case would MDR reporting be appropriate. In fact, this is something to be thankful about: MDR reports are public; NOT having to file public AEs/SAEs during a clinical trial might save us some embarrassment.
Hi, I realize this thread is a bit old but can you reference in which standard or where it is stated when you say "In NEITHER case would MDR reporting be appropriate."? Thanks !
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