Regulatory Open Forum

Can someone point me to a regulation or a guidance which talks about the number of deficiencies a sponsor can get per Module for a PMA submitted for a Medical device? 

For 510ks, the number of additional information deficiency is only one but not sure about PMA. 

Anon,

I am not sure of the question being asked, but there is not a "number" of deficiencies which may give success or no success to a PMA approval.  As example, if there were only 3 deficiencies for the PMA, but these were significant, US FDA may already stop the review process.  So there is not a specific number whether a PMA will get approved or not.

Can someone point me to a regulation or a guidance which talks about the number of deficiencies a sponsor can get per Module for a PMA submitted for a Medical device? 

For 510ks, the number of additional information deficiency is only one but not sure about PMA. 

Can someone point me to a regulation or a guidance which talks about the number of deficiencies a sponsor can get per Module for a PMA submitted for a Medical device? 

For 510ks, the number of additional information deficiency is only one but not sure about PMA. 

I am guessing that Anon is asking how many rounds of deficiency questions are possible per module with a modular PMA. I am not aware of a guidance that sets a limit on this. It's been a few years since my last modular, but my experience has been that until a module is closed FDA can always come back with follow-up deficiencies based on the manufacturer's response. Since the MDUFA clock doesn't start until your last module goes in and your PMA is complete, I don't think there is a statutory timeline by which FDA has to close the first modules. While unusual, I have even had FDA come back on an open module with a completely new deficiency topic after the first round was addressed. In this instance, the follow-on deficiency was prompted by new information provided in the next module. However, once your final module goes in, FDA will then drive to the 180-day MDUFA clock.

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Julia Anastas
San Carlos CA
United States

Original Message:
Sent: 27-Jun-2023 01:33
From: Anonymous Member
Subject: Number of Deficiencies under Modular PMA per Module

This message was posted by a user wishing to remain anonymous

Can someone point me to a regulation or a guidance which talks about the number of deficiencies a sponsor can get per Module for a PMA submitted for a Medical device? 

For 510ks, the number of additional information deficiency is only one but not sure about PMA. 

Hello Anon

Julia has responded to your question very well. You could get many rounds of deficiencies until you close that module. Each deficiency will be an amendment to your Module under review.

I am guessing that Anon is asking how many rounds of deficiency questions are possible per module with a modular PMA. I am not aware of a guidance that sets a limit on this. It's been a few years since my last modular, but my experience has been that until a module is closed FDA can always come back with follow-up deficiencies based on the manufacturer's response. Since the MDUFA clock doesn't start until your last module goes in and your PMA is complete, I don't think there is a statutory timeline by which FDA has to close the first modules. While unusual, I have even had FDA come back on an open module with a completely new deficiency topic after the first round was addressed. In this instance, the follow-on deficiency was prompted by new information provided in the next module. However, once your final module goes in, FDA will then drive to the 180-day MDUFA clock.

------------------------------
Julia Anastas
San Carlos CA
United States

Original Message:
Sent: 27-Jun-2023 01:33
From: Anonymous Member
Subject: Number of Deficiencies under Modular PMA per Module

This message was posted by a user wishing to remain anonymous

Can someone point me to a regulation or a guidance which talks about the number of deficiencies a sponsor can get per Module for a PMA submitted for a Medical device? 

For 510ks, the number of additional information deficiency is only one but not sure about PMA.