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ACRP 2019 OnDemand


232 - EFS is the new OUS strategy for early-phased medical device clinical trials


Apr 13, 2019 10:15am ‐ Apr 13, 2019 11:15am


Credits: None available.

Non Member: $75.00
Members: $15.00

Description

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue fo regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

Learning Objectives:

  • Define FDA's Early Feasibility Study (EFS) Program.
  • Outline the risks/benefits of participating in the EFS program for early-phased clinical trials.
  • Outline strategies to leverage EFS protocols for PMA and 510 submissions.

Speaker(s):

  • Christopher Cain, CCRA, RAC, VP, Clinical and Regulatory Affairs, Conformal Medical, Inc.
  • Victor Chen, Director, Clinical Affairs, Align Technology
  • Maureen Dreher, Ph.D, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health

Credits Available


EFS is the new OUS strategy for early-phased medical device clinical trials Exam

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