B
Thanks, I should have been more specific. Our device is a wound dressing containing a silver antimicrobial. The product code for these devices is technically "unclassified", but is most commonly treated as Class II. In the past we have submitted accelerated aging data and noted that real-time aging is in process and would be completed according to the same protocol. It has not been difficult in the past to justify the use of accelerated aging data for these devices.
A requirement to develop the product then sit on it for at least another year in order to have enough data to submit for a decent shelf life claim seems like it would be a barrier to new start-ups especially in a highly competitive market.
At this point we are hoping that it is as you said, a miscommunication or misunderstanding between our consultant and FDA, but I am very rarely surprised anymore.
A requirement to develop the product then sit on it for at least another year in order to have enough data to submit for a decent shelf life claim seems like it would be a barrier to new start-ups especially in a highly competitive market.
At this point we are hoping that it is as you said, a miscommunication or misunderstanding between our consultant and FDA, but I am very rarely surprised anymore.
