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CDRH Town Hall

Track:
Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 17, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
216

Room Number:
11A

Level:
Basic

Type:
Forum

Title:
CDRH Town Hall

Chair(s):
Janet Jenkins-Showalter
Senior Regulatory Group Director, Regulatory Policy and Intelligence
Genentech, A Member of the Roche Group, United States

Description:
This forum will provide a unique opportunity to hear from the director of the Center for Devices and Radiological Health (CDRH) who will report on the state of CDRH and its vision for the future. Topics to be addressed include: FDASIA accomplishments and activities; the view toward 2017 MDUFA Reauthorization; companion diagnostics and personalized medicine; investigational device exemptions for in vitro diagnostic products (including companion diagnostic products); FDA’s Unique Device Identification (UDI) program; regulation of mobile and web software applications; CDRH’s Case-for-Quality Initiative – promoting device quality in the global marketplace; and public-private partnerships, ie, Medical Devices Innovation Consortium (MDIC) and other CDRH innovative programs.

Please come prepared with your questions for the CDRH panel. You may submit questions and topics of interest in advance to annualmeetingprogram@diahome.org, and include “CDRH Panel” in the subject line.

Learning Objective(s):
Discuss key hot topics for CDRH; Identify priorities and challenges for the future.

Presentation(s) & Speaker(s):
Panelist
Jeffrey Shuren, JD, MD
Director, CDRH
FDA, United States

Panelist
Alberto Gutierrez, PhD
Director, Office of In Vitro Diagnostics and Radiological Health, CDRH
FDA, United States

Panelist
Christy L. Foreman
Director, Office of Device Evaluation, CDRH
FDA, United States

Panelist
Kirsten H. Paulson, MS, RAC
Senior Director, Global CMC-Medical Devices
Pfizer Inc, United States

Panelist
Michelle McMurry-Heath, MD, PhD
Associate Director for Sciences, CDRH
FDA, United States