Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon

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

Day & Time:
June 24, 11:00AM - 12:30PM

Session Number:
112

Room Number:
253C

Level:
Intermediate

Type:
Forum

Title:
Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon

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

Description:
Following the recent passage of the MDUFA, there will be many challenges ahead to implement the new legislation. This forum will focus on understanding the way forward and the key initiatives for CDRH in the post-user fee reauthorization era. CDRH Senior Staff will discuss their priorities and challenges and provide their perspective on areas that are expected to be the focus of external stakeholders.

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

Panelist
Alberto Gutierrez, PhD
Director, Office of In Vitro Diagnostic Device Eval and Safety, CDRH
FDA, United States