Name
Medical Devices 101 Breakout: Categorizing Medical Devices - IDE, Assessing Risk Level, and What the IRB Will Want To Know
Date & Time
Monday, October 17, 2022, 10:45 AM - 11:30 AM
Location Name
Wilshire AB
Description
Requirements of IRB review of medical device studies include a risk level assessment and an understanding of regulatory pathways for marketing approval.
Speakers
Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemanext
Andrea Itskovich - IRB Chair/Vice Chair (Medical) - WCG IRB
Rachel Lally - Executive Director, Human Research Protection Program - Penn State University
Andrea Itskovich - IRB Chair/Vice Chair (Medical) - WCG IRB
Rachel Lally - Executive Director, Human Research Protection Program - Penn State University
Learning Objectives
- Describe medical device risk levels and explore the IRB assessment process.
- Recognize alternative approval pathways of humanitarian use devices (HUD) and compassionate use of medical devices.
- Identify special IRB review requirements for medical device software and mobile medical devices.