PRIM&R TRAINING
Introduction to Medical Device Research and Making the Risk Determination
Date: Wednesday, June 17, 2009
Time: Noon-1:30 p.m.
Location: Alec Conference Room, ECJ 1.300
Overview
This device-specific webinar, designed by the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, focuses on basic information members of institutional review boards (IRBs) should know about medical device research including the sponsor and clinical investigator responsibilities. This webinar will also cover the FDA’s recommended procedures of how an IRB should meet its regulatory requirement to make a risk determination of non-significant risk device studies. In addition, there will be a brief demonstration of how to locate PMA and 510(k) devices labeling information.
Agenda
- Introduction to Investigation Device Exemption (IDE)
- Discussion about when an IDE is necessary and when it is not
- Sponsor responsibilities and interactions with IRB
- Clinical investigator responsibilities and interactions with IRB
- IDE studies supporting marketing applications
- Tools to find approved labeling of cleared 510(k)s and Premarket Approvals
- 21CFR 812.66 the IRB responsibility to make a risk determination
- The IRB Significant Risk vs. Non-significant Risk Determination
- Discussion of significant risk device
- How IRB's should go about determining the risk of a non-significant risk device study
- The role of the sponsor, clinical investigator, IRB, and FDA
Please register online via TXClass. This class is listed as RC307
If you have questions about registration call (512) 471-8726 or email ckrisher@austin.utexas.edu
News Archive:
Note: This archive is maintained for reference purposes. All listed events have already taken place.