Medical Devices

Public Workshop - Patient and Medical Professional Perspectives on the Return of Genetic Test Results, March 2, 2016

The Food and Drug Administration (FDA) announced the following public workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this workshop was to understand patient and provider perspectives on receiving genetic test results. The topic(s) discussed focused on better defining the specific information patients and providers prefer to receive, how those results should be returned, and what information is needed to understand the results so that they may effectively aid in medical decision making.

Date, Time and Location

This meeting will be held March 2, 2016, beginning at 8:00 am–4:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Webcast Archive

Preliminary Agenda

8:00 amIntroductionBruce Kuhlik, Senior Advisor to the Commissioner, Food and Drug Administration
8:10am-8:25amWhite House SpeakerJo Handelsman, PhD, Associate Director for Science in OSTP
8:25am-8:40amNIH SpeakerKathy Hudson, PhD, Deputy Director for Science, Outreach and Policy
8:40am-8:50amFDA SpeakerLiz Mansfield, PhD, Deputy Director for Personalized Medicine
8:50am-10:00amWell Patient Tests/Predictive testsModerator: Cara Tenenbaum, JD, CDRH

Sara Weir, National Down Syndrome Society
Tracy Trotter, MD, San Ramon Valley Primary Care
Margot Savoy, MD, MPH, FAAFP, Family Medicine Center-Christiana
Ellen Matloff, MS, CGC, My Gene Counsel
Steven J. Ralston, MD, Beth Israel Deaconess Medical Center
10:20am-11:30pmAcute Disease Tests

Moderator: Laura Koontz, PhD, CDRH

Lisa Schlager, Facing Our Risk of Cancer Empowered
Annie Kennedy, Parent Project Muscular Dystrophy
Girish Putcha, MD, PhD, Palmetto GBA
Barbara Biesecker, PhD, NHGRI
Carolyn Hendricks, MD, Maryland Oncology Hemotology

12:30pm-1:35pmChronic Disease TestsModerator: Katherine Donigan, PhD, CDRH

Francis J. McMahon, MD, National Institute of Mental Health
Anna McCollister-Slipp, Scripps Translational Science Institute
Kiran Musunuru, MD, PhD, MPH, Harvard University
Amy Sturm, MS, CGC, The Ohio State University, National Society of Genetic Counselors
Allen Doederlein, Depression and Bipolar Support Alliance
1:50pm-3:30pmPublic Comment 
3:30pmClosing RemarksDr. Jeff Shuren, MD, JD, Director, CDRH

Case Studies Documents

Registration to Attend the Workshop

Registration is closed as of February 24, 2016. On-site registration will be available the morning of the workshop.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661,

For questions regarding workshop content please contact:

Cara Tenenbaum, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66 rm. 5563, Silver Spring, MD 20993, 301-796-8456, email:

Page Last Updated: 05/05/2016
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