Kelly Lindblom, Ph.D., R.A.C.
Regulatory Affairs Scientist
Duke University School of Medicine
This workshop will offer best practices when conducting trials using FDA approved and unapproved devices. It will give an overview of the marketing process for medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation.
This workshop will address the following questions (and more):
- What is a medical device?
- What is FDA’s approach to regulating the commercialization of medical devices?
- What is the 510(k) pathway?
- How does FDA regulate mobile apps?
- What are the benefits of a pre-submission meeting with the FDA?
- What is an abbreviated IDE and when is this applicable?
- What is the difference between an abbreviated IDE and a “full” IDE and when is the “full” IDE applicable?
- What information needs to be included in an IDE?
- How do I submit my IDE application to the FDA?
- What are the reporting requirements once my IDE is approved?
This course is designed for anyone directly involved in conducting investigator-initiated trials:
- Regulatory Personnel
- Clinical Research Nurses
- Clinical Research Associates
Kelly Lindblom, Ph.D., is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Lindblom is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Lindblom is also involved in the implementation of educational initiatives within ORAQ.
Lindblom received her undergraduate degree in chemistry from the University of North Carolina-Chapel Hill. She conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. Her research focused on the regulation of cell death in the context of Non-Alcoholic Steatohepatitis and different types of cancer. During her graduate training, Lindblom was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. Lindblom was the Assistant Director of Research Initiatives in the Office of the Vice Provost for Research at Duke University before joining ORAQ.