- Introduction
- Date and Location
- Eligible Participants
- Registration
- Contact Us
INTRODUCTION
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.
There is no registration fee for this program. However, attendees are responsible for their own travel expenses. The Forum will be held at The Sheraton Rockville Hotel, 920 King Farm Boulevard, in the Rockville/Washington DC Metropolitan area.
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
(240) 912-8200
ELIGIBLE PARTICIPANTS
Participation in the Advanced CDRH Forum for International Medical Device Regulatory Authorities is limited to international medical device regulatory authorities. Priority seating will be given to participants who have previously attended CDRH’s Introductory Device Forum course.
Confirmation of registration and additional meeting information will be sent to approved participants.
** Registration will close August 31, 2011. Please be sure to allow enough time to obtain your visa. **
Prior to the CDRH Forum, we request participants to view the following CDRH Learning Modules using CDRHLearn:Â
- Overview of Regulatory Requirements: Medical Devices
- Quality System Regulations 21 CFR 820 Basic Introduction
- Overview of Premarket Notification Process 510(k)
REGISTRATION
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at [email protected] at least 7 days in advance of the meeting.
CONTACT US
For further information, contact:
CAPT Paula Simenauer
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
Email: [email protected]