Investigational Devices: How the IRB Makes Device Determinations, and Sponsor and Investigator Responsibilities

The Office of Human Subjects Research Protections (OHSRP) Education Series session on April 7th from 3-4 PM will cover “ Investigational Devices: How the IRB Makes Device Determinations, and Sponsor and Investigator Responsibilities. ” Our speakers are Dr. Jonathan Green, OHSRP Director and Lisa Goldfeder, Section Head, Regulatory Support Section, Office of Research Support and Compliance. Topics for discussion related to use of investigational devices in human subjects research include: • How the IRB makes device determinations: When is a device an investigational device? • Exempt vs. non-significant risk (NSR) vs. significant risk (SR) devices • Information required in the protocol • PI and sponsor responsibilities for various categories of devices uses (e.g., applicable FDA regulations for SR vs. NSR)Air date: 4/7/2022 3:00:00 PM
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video