Greater Cincinnati: Demystifying the Compassionate Use Device Exemption Process

When:  Mar 14, 2018 from 5:30 PM to 8:15 PM (ET)

Demystifying the Compassionate Use Device Exemption Process

  • Michael E. Snyder, MD
  • Jessica Wessel, CCRC, COA
  • Robert Romanchuck, BHS, CIP, CCRCP, CCRC
Registration Cost:
  • $0 (Free) Chapter Members
  • $15 ACRP Members
  • $30 Non-Members
Program Agenda:
  • 5:30 –6:00 pm – Registration & Networking
  • 6:00 - 7:00 pm – A Better Understanding of Compassionate Use Device Exemption
  • 7:00 – 8:00 pm – Expanded Access to Investigational Drugs and Devices
  • 8:00 – 8:15 pm – Q&A/Discussion
The Process of Compassionate Use Device Exemption. Perspectives of an Investigator, Research Coordinator, & the IRB

Program Description: This interactive presentation focuses on providing the audience with a better understanding of Compassionate Use Device Exemption. Providing a breakdown of what processes need to take place in order to make these cases possible when the existing and alternative available therapies are suboptimal. This session will clarify standards for submissions, approvals, treatments, and closeouts.

Upon completion of this Meeting with Live Speakers, attendees should be able to:
  • Understand Compassionate Use Device Exemption (CUDE) and the need to use an Unapproved Device
  • Understand the process of obtaining approval for CUDE
  • Understand the role and responsibilities of the Physician, Clinical Research Staff, and IRB in the Compassionate use of unapproved FDA devices
Target Audience: Anyone involved in Clinical Research

Contact hours: 2.0 Contact hours (ACRP, CBRN, ACCME) are available through ACRP. Membership is not required for online registration of contact hours.

To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:
  • $0 Chapter Members
  • $15 ACRP Members
  • $30 Non-Members
Refund Policy: All cancellation requests must be made in writing and received at least 15 calendar days prior to the day of the course. Cancellation requests received after this time will not be refunded.

Level: Intermediate-Level (2-5 years of experience)

Further Information: For questions, Contact the Chapter through email at


Cincinnati Eye Institute
Founders Room B
1945 CEI Drive
Cincinnati, OH 45246
Event Image


ACRP Greater Cincinnati Chapter