MDUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know – Webinar Recording/Transcript
After much debate, Congress was unable to come to an agreement on MDUFA V and passed a stripped-down reauthorization of the user fee amendments. New initiatives and programs the FDA and industry hammered out were left on the table.
What does this stripped-down package contain? What did Congress leave out? What does the future hold for the revisions to the real-world evidence and presubmissions guidance documents? What about the anticipated expansion of FDA authority over laboratory-developed tests?
Jessica Ringel, a partner in King & Spalding’s FDA and Life Sciences practice group, explains what you must know about the recently enacted MDUFA V and what’s to come.
She’ll shed light on the changes in user fees and the commitments the FDA’s Center for Devices and Radiological Health (CDRH) has made to the device industry in connection with its performance on marketing applications and related premarket processes — and what that could mean for you.
- Budget for future marketing applications by understanding the increases in user fees being assessed for device applications
- Understand CDRH’s timeline commitments so you can better anticipate its marketing application review and the potential effects on timing of new device market launches
- Know when to expect certain guidance documents the FDA has promised to issue over the next few years as part of its MDUFA V commitments, including revisions to the guidance documents on real-world evidence and presubmissions
- Get a handle on the FDA’s new Total Product Life Cycle Advisory Program (TAP) pilot, the program’s potential benefits and whether your devices may be eligible
- Recognize which anticipated changes were left out of the reauthorization legislation — including the VALID Act regarding in vitro diagnostic devices and laboratory-developed tests — and what may be next for the unenacted changes
Congress has only two months to revive and resolve these issues before new legislators —with potentially different agendas — take their seats in January.
Time will move quickly. Prepare for the inevitable changes by listening to this crucial presentation today.
Meet Your Presenter
Jessica Ringel is a partner in King & Spalding’s FDA and Life Sciences practice group. She advises medical device companies on matters across the spectrum of FDA regulation, with a focus on postmarket safety and quality matters, including responses to FDA inspections and enforcement actions, conducting recalls and reporting adverse events. Ms. Ringel also advises companies on FDA-compliant promotional practices. Her premarket practice includes identifying marketing pathways and the preparation of premarket submissions to the FDA.
Who Will Benefit
Anyone whose job involves compliance with FDA premarket requirements for medical devices, including:
- Executives in R&D
- Regulatory affairs personnel
- Legal/compliance professionals
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Nov. 10, 2022