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boston745

07/16/16 12:11 PM

#5452 RE: MicTrade4490 #5451

Turns out fda requires packagers to register as contract manufacturers and they update this info yearly so this may not be anything new.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice /RegistrationandListing/ucm053165.htm

When I toured Amda facility last year they had a vendor that handled sterilization & packaging that was nearby. Biomerics was likely that vendor and they are located just 2 miles away.