Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Everyone,

I work with a Class III medical device company and we have multiple products that fall under the same category of generic device type. There is a trend in the deficiency questions received from the agency for one product application which seems to overlap with other future applications we submit.

I was hoping if you all can recommend any tools or methods that might be utilized to help with better tracking the deficiency questions? This will ensure we are providing the agency with a well put together submission and address any concerns upfront improving our approval timelines.

Thank you for your help in advance!

It will be interesting to see if there is any such tool. I’m also looking for it.

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Ritam Priya
VP Quality & Regulatory

Fremont CA
United States
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Original Message:
Sent: 23-Nov-2020
From: Anonymous Member
Subject: FDA Deficiency Question Tracking for Future Submissions

This message was posted by a user wishing to remain anonymous

Hello Everyone,

I work with a Class III medical device company and we have multiple products that fall under the same category of generic device type. There is a trend in the deficiency questions received from the agency for one product application which seems to overlap with other future applications we submit.

I was hoping if you all can recommend any tools or methods that might be utilized to help with better tracking the deficiency questions? This will ensure we are providing the agency with a well put together submission and address any concerns upfront improving our approval timelines.

Thank you for your help in advance!