Medical device Reporting : Good Faith Effort for Additional information

#1
Hi,
FDA only directs manufacturers to ensure they do a good faith effort to get additional information for complaints. Three attempts being the usual standard seems like a reasonable number, but is there any recommended number of days between these attempts?
 
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shimonv

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#2
The FDA rarely goes to such "low-level" QA specifics, and if they did it would have made the life of the manufactures very difficult.
I would not define the interval between attempts in the complaint procedure; it's way too specific, and in days like ours (COVID -19) you wouldn't be able to follow it.

Shimon
 

Watchcat

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#3
I concur with shimonv (like the new pic!) but will add that I personally might balk at the amount of "good faith" behind the same email sent out three days in a row (or hours or minutes).

If your goal is to get additional information, rather than simply to comply as quick and as easily as possible, I would worry less about how many days between attempts and more about the medium(s) used. I would not send three emails myself, but would make at least one of the attempts by phone. Moreover, if I had more than one number (e.g., the doctor's office and his department head's), I would try more than one. Sending three emails strikes me as putting Einstein's definition of insanity into practice.
 
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