Dr. Allison Komiyama is the Principal consultant of AcKnowledge Regulatory Strategies. She is a former FDA reviewer with expertise in medical device and combination product submissions. While working at FDA in the Office of Device Evaluation, she 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.
Allison likes to work with FDA to ease the review process and get your device on the market as soon as possible. Acknowledging that each medical device needs a specific and tailored strategy to earn regulatory clearance, her goal is to ensure that you have well-defined expectations to see your technology brought to market. She can help your company with a regulatory plan, and your 510(k)/PMA/IDE/RFD/Pre-Sub/de novo submissions.