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Are you a contract manufacturer or an OEM?
If you are an OEM, change in shelf life / expiration date is a modification and FDA may require a new 510(k). Is a new 510(k) required for a modification to the device?
If you are a contract manufacturer, these changes would be customer dictated. Is the expiration date extension at a product level or happening on a batch-to-batch basis? Are there any triggers that kick start this process?
Are you a contract manufacturer or an OEM?
If you are an OEM, change in shelf life / expiration date is a modification and FDA may require a new 510(k). Is a new 510(k) required for a modification to the device?
If you are a contract manufacturer, these changes would be customer dictated. Is the expiration date extension at a product level or happening on a batch-to-batch basis? Are there any triggers that kick start this process?