I'll begin by reviewing what Mr. Turnbull provided a few moments ago. The concern paper is a note. It's to determine that there has been an area where further clarification is needed in order for the validating authority to fully understand how the certifying authority has said the manufacturer achieved compliance. It's not to specify that there is a particular safety issue. It's to specify that more information is needed.
Throughout the iterations of the concern paper, the validating authority will make a determination. Is this an issue that needs to be closed prior to issuing a validation, or is this an issue that does not pose a safety risk but might be an issue, where the four certifying authorities have to regroup and say, “How are we harmonizing the standard? We're looking at it from this way. You're looking at it from this way, and we need to make sure we have a common understanding”?