Date: February 23, 2017
Time: 10:00 am - 11:00 AM
Location: Academic Learning and Teaching Center Room 2.220
What Does It Take To Get FDA Approval?
Date: Thursday, Feb. 23, 2017
Time: 10:00 a.m. - to 11:30 a.m.
Where: Academic Learning and Teaching Center Room 2.220
What: Dr. Allison Komiyama, principal consultant at AcKnowledge Regulatory Strategies will be speaking about how to have well-defined expectations to see your technology brought to market.
While working at FDA in the Oce of Device Evaluation, Dr. Komiyama acted as a lead reviewer and consult on 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Premarket Approval (PMA) submissions. Her additional specialty was in biocompatibility requirements for implanted devices.
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