Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities, September 14-16, 2009

Rockville, Maryland

INTRODUCTION

The United States Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH) is pleased to announce a CDRH Forum for International Medical Device Regulatory Authorities scheduled for September 14-16, 2009. 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 offered in Rockville, Maryland.

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

CDRH Forum

CDRH Forum for International Medical Device Regulatory Authorities
September 14-16, 2009
Hilton Washington DC/ Rockville Executive Meeting Center
1750 Rockville Pike
Rockville, Maryland 20852 USA
www.rockvillehotel.com (the hotel will provide a special rate for a limited number of attendees of 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.

All registration requests must include the following information

• Name
• Title
• Position
• Agency
• Contact information (email, phone and complete mailing address)

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)

For further information, contact:

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

APPLICATION

Name:
Title:
Position:
Agency:
Email:
Phone:
Address: