FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA: CDRH Presentations

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This webinar, presented September 4, 2024, offers essential insights into medical device development, guiding innovators through complex regulatory and market pathways. The Division of Industry and Consumer Education (DICE) serves as a primary resource at the Center for Devices and Radiological Health (CDRH), providing direct assistance with general medical device regulatory questions and creating valuable educational materials like Device Advice webpages, CDRH Learn videos, and Guidance Documents. DICE emphasizes the importance of early engagement with regulatory education and highlights the Q-Submission program for pre-submission consultations with FDA experts. Furthermore, the Medical Device Development Tools (MDDT) program is introduced as a voluntary pathway for qualifying tools that assess device safety, effectiveness, or performance, ultimately reducing regulatory burden and streamlining the review process. Lastly, the Early Payer Feedback Program addresses the critical step of ensuring patient access beyond FDA market authorization. This program facilitates early communication between device sponsors and payers, allowing for the alignment of clinical evidence requirements and potentially accelerating device availability to patients by integrating payer needs into pivotal clinical trial designs.

This session includes three presentations:

"How Can DICE Help You?"
Giselle Blanco
Consumer Safety Officer
Premarket Programs Branch (PPB)
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE)
Center for Devices and Radiological Health (CDRH)
US Food and Drug Administration (FDA)

"Medical Device Development Tools Program"
Jessica Mavadia-Shukla, PhD
Director, Medical Device Development Tools Program
Division of Partnerships and Innovation (DPI)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health (CDRH)
US Food and Drug Administration (FDA)

"Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force"
Danielle Fau, MSE
Senior Advisor for Technology and Innovation
Division of Health Equity (DHE)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health (CDRH)
US Food and Drug Administration (FDA)