Allison C. Komiyama PhD, RAC

Allison is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. She started AcKnowledge Regulatory Strategies in order to serve clients who manufacture implantable and other patient-contacting medical devices. She received her Ph.D. in Neuroscience from Stanford University and her B.A. in Molecular and Cell Biology from University of California, Berkeley. While working at FDA as a biologist and reviewer 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 specialty was in biocompatibility requirements for implanted devices. She also researched neurotoxicity and systemic toxicity of medical devices in the Office of Science and Engineering Labs in support of FDA recognized ISO and ASTM standards. After her time at FDA, she worked as a project manager and regulatory affairs manager at an in vitro diagnostic device company, as well as a senior regulatory specialist at a boutique consulting firm.