Investigational Device Exemptions (IDE) and Genomics Workshop

June 10, 2016

5635 Fishers Lane
Conference Center (Terrace Level)
Rockville, Maryland 20852

On June 10, 2016, the National Human Genome Research Institute (NHGRI) hosted a day-long, public workshop - Investigational Device Exemptions (IDE) and Genomics Workshop. The purpose of this workshop is educational. The Food and Drug Administration (FDA) may require an IDE for research involving the use of genomic technologies, including next-generation sequencing (NGS).

This workshop brought together perspectives from investigators, institutional review boards (IRB), the FDA and NHGRI on how to determine if a study requires an IDE and how to fulfill IDE requirements.

Video Playlist | Speaker Bios | Workshop Report 

Agenda

Time	Topic	Speaker(s)
8:00 a.m.	NHGRI Introduction Video	Eric Green M.D., Ph.D. NHGRI
8:10 a.m.	Charge for the Day and Logistics Video	Cristina Kapustij, M.S. NHGRI
8:20 a.m.	Policy Context of IDEs Video | Slides	David Litwack, Ph.D. Food and Drug Administration
8:45 a.m.	Session I: What is an Investigational Device in the Context of Genomics Research? Video | Slides (Kingsmore) Video | Slides (Caposino) Video (Panel)	Stephen Kingsmore, M.D., D.Sc. Rady Children's Institute for Genomic Medicine Paula Caposino, Ph.D. Food and Drug Administration
9:45 a.m.	Break
10:00 a.m.	Session II: Analytical Validation and IDEs Video | Slides (Berg) Video | Slides (Liang) Video | Slides (El Mubarak) Video (Panel)	Jonathan Berg, M.D., Ph.D. University of North Carolina Sharon Liang, M.D., Ph.D. Food and Drug Administration Haja El Mubarak, Ph.D. Food and Drug Administration
11:00 a.m.	Session III: Risk Assessment Video | Slides (Seidman) Video Slides (Chandros Hull) Video (Panel)	Jeffrey Seidman, M.D. / Kellie Kelm, Ph.D. Food and Drug Administration Sara Chandros Hull, Ph.D. NHGRI
12:15 p.m.	Lunch
1:15 p.m.	Session IV: Risk Assessment Case Studies Video | Slides (Panel)	Laura Lyman Rodriguez, Ph.D. NHGRI Anastasia Wise, Ph.D. NHGRI Kellie Kelm, Ph.D. Food and Drug Administration
2:40 p.m.	Break
2:50 p.m.	Session V: Steps after Determining Risk Video | Slides (Berglund) Video | Slides (Litwack) Video (Panel)	Jelena Berglund, Ph.D., R.A.C. Duke Translational Medicine Institute David Litwack, Ph.D. Food and Drug Administration
3:50 p.m.	Summary of the Day
4:00 p.m.	Adjourn

Additional Resources

Please contact the Policy and Program Analysis Branch with questions regarding the resources on this page.

The Duke Translational Medicine Institute offers a free, 6-8 week Medical Device Regulatory Training Program that explains IDE submissions.