The United States Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH) is pleased to announce their CDRH Forum for International Medical Device Regulatory Authorities scheduled for May 3-6, 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.
The CDRH Forum for International Medical Device Regulatory Authorities provides information about the U.S. medical device regulatory processes in an organized and integrated manner. It will explain the role of CDRH as well as the science, technology, regulations and processes used to do our work.
The forum was held from May 3-6, 2011, at the following location:
Gaithersburg Washingtonian Marriott
9751 Washingtonian Boulevard
Gaithersburg, Maryland 20878 USA
(301) 212-6155 - Fax
Participation in the CDRH Forum for International Medical Device Regulatory Authorities is limited to international medical device regulatory authorities. Confirmation of registration and additional meeting information will be sent to approved participants.
Prior to the CDRH Forum, we request active participants view the following CDRH Learning Modules using CDRHLearn:
- Overview of Regulatory Requirements: Medical Devices
- Quality System Regulations 21 CFR 820 Basic Introduction
- Overview of Premarket Notification Process 510 (k)
*** NOTE: A second CDRH Forum will be held September 13-16, 2011 for more experienced international medical device regulatory authorities. More information will be posted on the website in June 2011. ***
For further information, contact:
CAPT Paula Simenauer
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration