Anon,
It really depends on what a "minor change" updating a Manufacturing document or how using a different cutter would affect the product safety and efficacy. When dealing with a Post Market Approval (PMA) even what may be considered minor changes to other medical devices need notification for PMA devices. You may still reach out directly to the main reviewer to query, the US FDA are fairly open these days and ask how they would handle the changes. Also keep in mind if there are cumulative or many changes, each individual change might be minor, but put all together may have an impact.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 14-Feb-2023 22:14
From: Anonymous Member
Subject: Evaluating manufacturing/design changes to a Modular PMA under review
This message was posted by a user wishing to remain anonymous
Richard,
Thank you for the feedback, much appreciate it. While, we are aware of the amendment approach for significant changes however for minor change like updating a Manufacturing document or using an automated cutter instead of a manual cutter, how would you recommend evaluating those changes while the module is either closed or open but before the PMA is approved?
Original Message:
Sent: 12-Feb-2023 20:00
From: Anonymous Member
Subject: Evaluating manufacturing/design changes to a Modular PMA under review
This message was posted by a user wishing to remain anonymous
We have submitted 3 of our 4 PMA modules for a medical device and our last module is the clinical module. We have our manufacturing module which is under review and our PAI scheduled in March 2023. While we have our PMA under review, we do have design and manufacturing changes which could impact the submission under review. These changes are bucketed into following categories:
- Manufacturing changes which can impact the impact the Manufacturing module is still under review at FDA
- Design changes which can impact the Device Verification module which is closed
- Certain changes which do not need prior approval but can be reported as Annually Reportable changes if the PMA was approved
- Can someone from the regulatory industry provide on how should we proceed with these types of changes?
- For the 3rd category of changes, would you recommend we summarize them in the last (Clinical) module and provide them to FDA or it is okay to report them in our first annual report?
- Also if there are any FDA guidance which we can refer to, that will be great.