NIH

Investigational Device Exemptions (IDE) and Genomics Workshop

Double helix branding used for IDE 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 PDF file

Workshop Report PDF file

Agenda

Time Topic Speaker(s)
8:00 a.m.

NHGRI Introduction

YouTube video Video
Eric Green M.D., Ph.D.
NHGRI
8:10 a.m.

Charge for the Day and Logistics

YouTube video Video
Cristina Kapustij, M.S.
NHGRI
8:20 a.m.

Policy Context of IDEs

YouTube video Video | SlidesPDF file
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?

YouTube video Video | SlidesPDF file (Kingsmore)

YouTube video Video | SlidesPDF file (Caposino)

YouTube video 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

YouTube video Video | SlidesPDF file (Berg)

YouTube video Video | SlidesPDF file (Liang)

YouTube video Video | Slides PDF file(El Mubarak)

YouTube video 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

YouTube video Video | SlidesPDF file(Seidman)

YouTube video Video SlidesPDF file (Chandros Hull)

YouTube video 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

YouTube video Video | SlidesPDF file (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

YouTube video Video | SlidesPDF file (Berglund)

YouTube video Video | SlidesPDF file (Litwack)

YouTube video 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.

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Last Updated: June 22, 2016