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Manufacturing Process FDA FOIA

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#1
Good morning everybody,

Does anyone know if can I request information about a predicate manufacturing process?

It will be used to compare my subject device with the predicate to ensure that we have the same processes and our process does not raise issues about safety and effectiveness regarding biocompatibility.

Thanks!
 
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optomist1

A Sea of Statistics
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#2
Hi Steve,

Although on a totally different topic...my very current experience with the FDA FOIA process is not good, there seems to be different responses and query requirements depending upon who handles your request...I have not gotten a warm feeling about the voracity, completeness and accuracy of the FDA database

Hope this helps..
 

optomist1

A Sea of Statistics
Trusted Information Resource
#3
Hi Steve,

Again...Although on a totally different topic...I have discovered first hand that the FDA FOIA process is at best inexact and pseudo random. Only after 6-7 emails, was I able to guide the FDA FOIA folks as to how to modify their database search query...scary, so the upshot question everything...period. I believe that to a large degree they are filling the square...i.e. processing the FOIAs..

Best of luck..
 
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