Anna joined Syntactx (now part of NAMSA) in October 2020. She previously worked as a Lead Reviewer within the Vascular and Endovascular Devices Team at the U.S. Food and Drug Administration (FDA) for close to three years. While at the FDA, Anna managed and reviewed over 150 complex regulatory submissions for vascular and endovascular surgical devices, including pre-submissions, investigational device exemptions (IDEs), 510(k) premarket notifications, and premarket approval (PMA) related submissions. Additionally, she effectively led a complex PMA Panel-Track Supplement and several PMA 180-Day Supplements, PMA Real-Time Supplements and PMA 30-Day Notices. She also developed expertise as a subject matter expert in industrial sterilization and packaging validation strategy, conducting over 50 such reviews for teams across Center for Devices and Radiological Health (CDRH)/Office of Cardiovascular Devices (OHT2).  Anna received her doctoral degree from The University of Iowa (Iowa City, IA) in biomedical engineering, with research focused on the development of a nanometer-scale hemocompatible and antithrombotic surface coating for commercially-available neurovascular stents and flow diverters.

CORE COMPETENCIES

• Developing industrial sterilization and packaging validation strategies for medical devices
• Supporting the development of regulatory strategy for medical devices, including device evaluation strategy approaches to support various stages of medical device product development (e.g., early feasibility study, pivotal study, marketing submission)
• Supporting medical device test method development
• Providing support for the identification of options for clinical evaluation of new and modified devices, including clinical study synopsis and clinical protocol development
• Aiding in the development of regulatory strategy in response to FDA feedback and decision letters
• Preparing FDA submission, including writing and reviewing of regulatory documents (e.g., pre-submissions, IDEs, PMAs)
• Supporting presentations to the FDA

RECENT PROJECTS

• Developed a response strategy to bioburden and sterilization-related concerns cited by FDA in an official letter for a novel structural heart device
• Led the writing of an IDE for a novel/first of a kind peripheral device and provided support for all interactions with FDA
• Supported the writing of and led quality control efforts for the documentation to support a FDA Circulatory System Devices Advisory Committee Panel Meeting, as well as led the effort to triage questions to the client and connect them with appropriate supporting documentation
• Supported the writing of a Breakthrough Device Designation Request for an early-stage company with a novel software diagnostic technology and facilitated the overall development of the program strategy