What does it take for developers and innovators to study higher-risk medical devices in clinical trials? This UB CTSI Educational Modules video focuses on Investigation Device Exemption (IDE) studies and explores:
Developed and presented by Carlos Peña, PhD, MS, Chief Regulatory Officer/Chief Quality Officer, Jacobs Institute
Running Time: 8 minutes
Contact Carlos Peña, PhD, MS, Chief Regulatory Officer/Chief Quality Officer, Jacobs Institute, at firstname.lastname@example.org.
“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”: https://www.fda.gov/media/114034/download
Contact any of the nine CTSI cores for a list of services and resources offered, and for answers to your research questions.