Hannah Irwin
Director, Regulatory Affairs, at MCRA LLC
Hannah Irwin serves as a director within MCRA’s Regulatory Affairs department, where she supports the department with the drafting, compilation, review, and maintenance of regulatory submissions, with a focus on orthopedic and spine devices. She assists with the drafting and submission of regulatory documents to the FDA on medical device submissions and handles strategy, analysis, and development of medical devices, as it relates to preparation for FDA and Notified Body approval. Prior to joining MCRA in October 2015, Irwin worked in clinical and regulatory affairs for a medical device company and performed research for a biotech company. She received her Bachelor of Science with a major in Biology from James Madison University.
2:00-2:45 p.m.
Thursday April 24, 2025
Navigating Evolving FDA Priorities: Hot Topics & Global Insights
As the U.S. Food and Drug Administration (FDA) priorities continue to evolve, this session will explore key focus areas during pre-market reviews, including biocompatibility, data requirements for studies outside of the U.S., real world evidence, MRI safety, statistics, and digital health. Additionally, this session will provide insights on changes seen within the agency under the new administration and the potential impact to manufacturers. The session will also offer a high-level overview of similar regulatory trends being raised in the EU under the transition to MDR/IVDR.