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.
There is no registration fee for this program. However, attendees are responsible for their own travel expenses. The program will be held in Maryland (the Washington DC Metropolitan area). Additional details about the Device Forum location will be available in late February or early March 2011.
The training will be conducted in English. Translations will not be provided.
The forum will be held from May 3-6, 2011, Maryland (Washington DC Metropolitan area).
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. ***
Electronic registration closes on April 22, 2011.
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at firstname.lastname@example.org  at least 7 days in advance of the meeting.
For further information, contact:
CAPT Paula Simenauer
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
Email: CDRHForum@fda.hhs.gov