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Re: fuente post# 30385

Friday, 05/24/2013 9:03:41 AM

Friday, May 24, 2013 9:03:41 AM

Post# of 330631
Also important to note, although we won't know for sure until the final ruling is published, is the comment from the summary below:

The absence of a benefit in studies of pain following procedures other than breast surgery is consistent with the expectation that each device and each procedure represent a unique clinical situation for which effectiveness would have to be supported by clinical performance data.



http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM352560.pdf

In other words, even if the dental study meets the FDA requirments it might only be useful in obtaining clearance for that specific procedure and indication, not for general clearance. While any approval is good for BIEL, that's a very limited market.