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hondobud

10/23/15 3:18 PM

#13432 RE: mopar44o #13428

You know that is a good question about the Facility. The FDA just came out 2 days ago with a new proposed guideline draft (which they are now preparing to discuss with interested parties) for determining when a company has to re certify its manufacturing facilities or devices I'm not sure
I tried to read it but it was too technical for me. I think this would be a good question for investor relations.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM467414.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery