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Redacted pre-submission bundle that you would be willing to share

Dobby1979

Involved In Discussions
#1
Hi All.

I don’t suppose anyone has a redacted pre-sub bundle that they would be willing to share?

First time for a meeting with the FDA and want to ensure that I submit all that is required and with the correct detail.

Thanks in advance all
 
#2
Dobby,

FDA has specific guidance on their pre-sub programme: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.

The level of detail is up to you:

The more general your questions are, the more general = invaluable the FDA feedback will be. The more specific your questions are, the more detailed = valuable the FDA feedback will be.

An example:
say, you want to submit a device terminally sterilized with ethylene oxide. If you just say this in your pre-sub doc, then FDA will only tell you that you have to comply to ISO 11135:2014 in your sterilization validation. If you already present FDA a validation protocol in your pre-sub, then FDA will tell you whether the agency considers your validation approach adequate or, if not, what specific topics FDA expects to be addressed in the protocol.

HTH,

Gerhard
 

Dobby1979

Involved In Discussions
#3
Thanks for the reply Gerhard.

We don’t have a performance test plan but I would like to get feedback on sample size, e.g would a proposed analysis of 100 report demonstrate acceptable equivalence? What detail would they need to be able to answer?
 
#4
Dobby,

querying the guidance I gave you above for "sample size" leads to 9 hits, e.g.:

If your questions pertain to your nonclinical testing, we recommend that you provide a concise summary of the test plan that includes:
• an identification of the objective or purpose of the test
• the sample size and statistical methods
• a summary of the test methodology (if you are following a recognized standard, include the name of the standard and year of publication)
• the acceptance criteria and a rationale for the selection of these criteria.
Examples of general questions that are NOT conducive to a productive discussion:
[...]
• How large should the sample size be?
HTH, Gerhard
 
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