Center for Devices and Radiological Health’s (CDRH) Forum for International Medical Device Regulatory Authorities

February 7, 2011

Dear International Regulatory Colleague:

I am very pleased to announce that the next session of the United States Food and Drug Administration’s (US FDA) Center for Devices and Radiological Health’s (CDRH) Forum for International Medical Device Regulatory Authorities is scheduled for May 3-6, 2011 in Gaithersburg, Maryland (in the Washington, D.C. metropolitan area). CDRH established this unique Forum to facilitate the exchange of medical device regulatory information and perspectives between the US FDA and its foreign counterpart medical device regulatory agencies. Non-FDA attendance at and participation in this Forum is limited to staff from our foreign counterpart medical device regulatory authorities.

Dr. Lillian Gill, Senior Associate Director of CDRH, will again host this Forum. CDRH colleagues from several of the major offices at CDRH, including the Office of Device and Evaluation; the Office of Compliance; the Office of In-Vitro Diagnostics; the Office of Surveillance and Biometrics; the Office of Communication, Education and Radiation; and the Office of Science and Engineering Laboratories, will join Dr Gill during the Forum. Presentations and discussion will focus on the roles of these offices, as well as the science, technology, regulations, and regulatory processes used by scientists in these offices to help accomplish the public health responsibilities of the FDA with respect to the regulation of medical devices. Dr. Gill and her colleagues look forward to providing information about the U.S. medical device regulatory processes in an organized, integrated, and comprehensive manner, and, especially, to having in-depth discussions with our colleagues from counterpart regulatory agencies.

Further information on this Forum can be found in the information that accompanies this message. For any questions, please contact CAPT Paula Simenauer (contact information attached to this message) in CDRH.

We look forward to welcoming you and/or members of your staff to this Forum.

Sincerely,

---/s/---

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs
U.S. Food and Drug Administration

International Outreach to Foreign Embassies