The AANS/CNS Washington Committee’s Drugs & Devices Subcommittee invites you to join a discussion on the FDA’s Medical Device User Fee Amendments (MDUFA) and the upcoming reauthorization.
MDUFA provides critical resources to support medical device review activities at FDA’s Center for Devices and Radiological Health and establishes performance goals and processes that guide the review of new medical technologies. With the next reauthorization approaching, this webinar will provide an overview of how MDUFA works, how it is funded, and what happens as FDA, industry, Congress, and other stakeholders prepare for a new user fee agreement.
Bringing together perspectives from the FDA, medical device industry, and clinical community, the discussion will connect this federal program to neurosurgery — including the role neurosurgeons play in developing and evaluating new technologies and ultimately bringing them into patient care.
Featured Speakers:
- Kathryn Capanna, MBA — Associate Director, Office of Strategic Partnerships and Technology Innovation, US Food and Drug Administration
- Cory N. Criss, MD — Chief Operating Officer, Midwest Pediatric Device Consortium
- David McMullen, MD — Head of Medical Affairs, Neuralink
Moderator:
- Joshua M. Rosenow, MD — Chair, Drugs & Devices Subcommittee, AANS/CNS Washington Committee
