DIA 2013 49th Annual Meeting
Click here to go to the previous page
Regulatory Environment in the US: CDRH Panel Discusses What's on the Horizon
Track
:
Track 09: Medical Devices, In Vitro Diagnostics, and Combination Products
Program Code:
112
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
Location:
253C
CHAIR
:
Janet Jenkins-Showalter, (SCHNON), Senior Regulatory Group Director, Regulatory Policy and Intelligence, Genentech, A Member of the Roche Group, United States
SPEAKER
(S):
Jeffrey Shuren, JD,MD (SPKAGY), Director, CDRH, FDA, United States
Christy L. Foreman, (SPKAGY), Director, Office of Device Evaluation, CDRH, FDA, United States
Kirsten H. Paulson, (SPKSUP), Senior Officer, Medical Device Initiative, The Pew Charitable Trusts, United States Alberto Gutierrez, PhD (SPKAGY), Director, Office of In Vitro Diagnostic Device Eval and Safety, CDRH, FDA, 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. The forum will include panelists from patient and/or industry organizations and will allow opportunity for audience participation.
This session is a part of:
This session is a part of: