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U.S. Department of Health and Human Services

Medical Devices

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CDRH Forum for International Medical Device Regulatory Authorities, May 3-6, 2010

U. S. FOOD AND DRUG ADMINISTRATION
Center for Devices and Radiological Health

INTRODUCTION

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, 2010. 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 Rockville, Maryland with more information to follow in February 2010.

The training will be conducted in English. Translations will not be provided.

CDRH Forum

CDRH Forum for International Medical Device Regulatory Authorities
May 3-6, 2010
The Legacy Hotel and Meeting Center
1775 Rockville Pike
Rockville, Maryland 20852 USA
(301) 881-2300
(800) 225-1775
http://www.thelegacyrockville.com/index.phpExit Disclaimer
(the hotel will provide a special rate for a limited number of attendees to the CDRH Forum on a first-come-first-serve basis)

ELIGIBLE PARTICIPANTS

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.

The following form may be used for online registration. All fields are required. Please only submit this form once.

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(repeat for verification)
 

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, 2010 for more experienced international medical device regulatory authorities. The training will be an advanced session to include a case study of a medical device review (MDR) and a 510K process. More information will be posted on the website in June 2010. ***

For further information, contact:

Ms. Lily Ng, MSN, MPH
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
Email: CDRHForum@fda.hhs.gov