This simply means that BIEL should work with the CDRH because of the process that is going on right now. Don't believe that OSI wanted to cause any conflicts during the process. It does not matter how long it takes for FDA clearance, it has always been about re-classification right from the beginning! The FDA should respond within 60 days about the classification. Hopefully it happens, a few trials and clearance. Keep in mind that trials are going on right now!!!!!!!!!!!
Thanks, your post wast correct. The OSI is to make sure that if errors occurred, correct actions should be taken. Given the fact that re-class has not happened yet, there were no errors at the present time.