Class III PMA shelf life extension

#1
I am looking at a class III, non-electrical, non-medicinal, sterile, implantable device that is approved in the US. It currently has an approved shelf life of two years and real-time aging was completed to support the extension to change the shelf life from two to three years. There are no associated changes to the device materials or manufacturing processes to accommodate the shelf life extension, however the expiration date on the template for product labeling will be revised.


Would it be safe to say: According to Section III of Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process the decision on how to report the change could go one of two ways depending on the protocol having been approved or not by FDA. For the shelf-life extension to the device, the manufacturer has performed and completed accelerating and real-time aging and would evaluate physical, chemical, and biological stability of the device during storage. In terms of labeling this change would be considered minor.

However, if the manufacturers' protocol is new and not approved by FDA they would have to submit the results of accelerated and real-time aging conducted to assess whether the product remains as safe and efficient, as it should be within the whole extended shelf life. Although this change would be considered minor, stability studies would be required, as previous completed. The scope of the supporting date required by FDA, would be limited to the particular aspects that are changing. Thus, a real-time supplement would be required.

On the other hand, if the protocol had been approved by FDA then the manufacture could follow the periodic reporting route to document the change in the shelf life from two to three years. In this case, the results can be reported as part of annual report.
 
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planB

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#2
To my experience, such shelf-life changes are typically minor (for the USFDA) as long as product safety and performance is not affected. In any case, you may want to re-confirm with FDA directly: to my experience, FDA will readily provide you with a response for the expected (non-) reporting pathway.
 
#3
So it's safe to say that either a real-time supplement or annual report would need to be submitted for the expiration on the template for product labeling to be revised depending on if the protocol submitted to FDA was new or not?
 
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