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Re: ANTman2015 post# 49407

Tuesday, 11/29/2011 4:14:08 PM

Tuesday, November 29, 2011 4:14:08 PM

Post# of 59551
bogdan, it's very clear in agreement meetings with the FDA that there is written documentation.

"The applicant should draft meeting minutes and exchange these with the Agency for review/comment within 7 days following the meeting..."

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073604.htm

Not sure if FOIA covers these docs but I plan to request nonetheless.
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