Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
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Pre-IDE• FDA review: Main issue was related to theUsability <strong>Study</strong> (Feb’ 2010)• New Usability <strong>Study</strong> protocol was submitted aspart of pre-IDE meeting (Nov’ 2010) to avoid“surprises” in a new 510(k) submissionJuly2009Feb’2010Nov’201017