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Hi All,
Since topic on MDR reporting to FDA is lacking let's get this discussion started for all of you reporters out there.
I have a questions first actually: If the event was initialy reported to FDA via an MDR but was later deemed that the event is not an MDR reportable event, how does one cancel the previos report?
Thank you all!
Since topic on MDR reporting to FDA is lacking let's get this discussion started for all of you reporters out there.
I have a questions first actually: If the event was initialy reported to FDA via an MDR but was later deemed that the event is not an MDR reportable event, how does one cancel the previos report?
Thank you all!