FDA Investigational Device Exemptions (IDE): Overview and Application to Research Involving Magnetic Resonance Imaging

On October 6, 2022, the Office of Human Subjects Research Protections (OHSRP) Education Series will present “ FDA Investigational Device Exemptions (IDE): Overview and Application to Research Involving Magnetic Resonance Imaging. ” Our speakers will be Drs. Alan Koretsky, William Pritchard, and Laura Reoma. Dr. Koretsky is the NINDS Chief of the Laboratory of Functional and Molecular Imaging and Director of the NIH MRI Research Facility. Dr. Pritchard works in the NIH Center for Interventional Oncology and formerly served as a medical officer in FDA ’ s CDRH. Dr. Reoma is the Director of the NINDS Clinical Trials Unit where she oversees the centralized support for NINDS sponsored IND and IDE clinical trials. Topics that will be addressed include the following: • Device regulations in the context of clinical trials • Applicability of the IDE regulations and related guidance • Practical considerations • NINDS ’ approach to the IDE review process • Key expedited NSR reporting considerations for clinical teamsAir date: 10/6/2022 3:00:00 PM
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