Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

For the first time, we used a 3rd party reviewer (3PR) for a multi-function medical device. The team's first submission was admittedly hurried and had gaps. We got feedback once, and filled in the identified gaps, including dropping functions that were ineligible for 3PR. We were asked for clarification, and we filled those gaps in, too. The latest round was that there would be no more rounds of review, without anything telling us where the remaining gaps were. We can't get any additional information on where the remaining gaps were. Is this typical? Is it standard procedure for a 3PR to close a review with no new feedback?

Yes, reviewers will stop reviewing if progress is not sufficient to address the issues. The only way to know what happened is to see the details. One clue would be if the first and second rounds of review were about entirely different issues. This could be a clue suggesting the gaps were simply too numerous to fully explain to the submitter.  Sounds like you need expert regulatory advice outside of the 3PR process to get your program back on track.

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Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
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Original Message:
Sent: 11-Jul-2022 13:56
From: Anonymous Member
Subject: Third party reviewer issue with feedback

This message was posted by a user wishing to remain anonymous

For the first time, we used a 3rd party reviewer (3PR) for a multi-function medical device. The team's first submission was admittedly hurried and had gaps. We got feedback once, and filled in the identified gaps, including dropping functions that were ineligible for 3PR. We were asked for clarification, and we filled those gaps in, too. The latest round was that there would be no more rounds of review, without anything telling us where the remaining gaps were. We can't get any additional information on where the remaining gaps were. Is this typical? Is it standard procedure for a 3PR to close a review with no new feedback?

This message was posted by a user wishing to remain anonymous

Thank you. The second review did not suggest there were issues other than the specific ones the TPR had listed. The comments were very specific, and strongly suggested that was all that remained. The responses directly addressed addressed them. There was no clue that the gaps were wide or other than what had been identified. We were legitimately blindsided by the refusal to consider the filing any more.
Original Message:
Sent: 12-Jul-2022 17:56
From: Joy Frestedt
Subject: Third party reviewer issue with feedback

Yes, reviewers will stop reviewing if progress is not sufficient to address the issues. The only way to know what happened is to see the details. One clue would be if the first and second rounds of review were about entirely different issues. This could be a clue suggesting the gaps were simply too numerous to fully explain to the submitter.  Sounds like you need expert regulatory advice outside of the 3PR process to get your program back on track.

------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated (www.frestedt.com)
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com

Original Message:
Sent: 11-Jul-2022 13:56
From: Anonymous Member
Subject: Third party reviewer issue with feedback

This message was posted by a user wishing to remain anonymous

For the first time, we used a 3rd party reviewer (3PR) for a multi-function medical device. The team's first submission was admittedly hurried and had gaps. We got feedback once, and filled in the identified gaps, including dropping functions that were ineligible for 3PR. We were asked for clarification, and we filled those gaps in, too. The latest round was that there would be no more rounds of review, without anything telling us where the remaining gaps were. We can't get any additional information on where the remaining gaps were. Is this typical? Is it standard procedure for a 3PR to close a review with no new feedback?