The United States Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH) is pleased to announce an advanced session of the CDRH Forum for International Medical Device Regulatory Authorities scheduled for September 13-16, 2011. The CDRH Forum is established for the exchange of medical device regulatory information between the USFDA CDRH and its counterpart agencies in other countries. The training is limited to international medical device regulatory authorities.
This advanced session of the CDRH Forum for International Medical Device Regulatory Authorities is designed for experienced regulatory authorities. The course will utilize a seminar approach by presenting several case studies. The case studies will focus on premarket and postmarket regulatory processes, including premarket requirements, postmarket surveillance, and enforcement activities. All participants are expected to actively participate in addressing the various issues presented in each case.
The training will be conducted in English. Translations will not be provided.
DATE AND LOCATION
CDRH Forum for International Medical Device Regulatory Authorities
September 13-16, 2011
Sheraton Rockville Hotel
920 King Farm Boulevard
Rockville; Maryland; 20850
For further information, contact:
CAPT Paula Simenauer
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration