E6-14852. Risk Communication on Medical Devices: Sharing Perspectives

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

SUMMARY:

The Food and Drug Administration (FDA), in cooperation with the Advanced Medical Technology Association (AdvaMed), is announcing a public meeting entitled “Risk Communication on Medical Devices: Sharing Perspectives.” This 1-day workshop is intended to bring together various creators and recipients of medical device risk/benefit information to discuss how this information is developed, disseminated, and perceived; and to explore ways in which the process might be improved.

Dates and Times: The public meeting will be held on September 26, 2006, from 7:30 a.m. to 5 p.m. Online registration is available until 5 p.m. on September 25, 2006; however, onsite registration will be permitted if space remains (see the Registration section of this document for details).

ADDRESSES:

The public meeting will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852. Additional information about, and directions to, the facility are available on the Internet at http://marriott.com/​property/​factsheet/​wasbn. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

FOR FURTHER INFORMATION CONTACT:

For FDA: Margaret Tolbert, Center for Devices and Radiological Health (HFZ-230), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3240, e-mail [e-mail].

For AdvaMed: Ellen Bielinski by e-mail at [e-mail], by telephone at 202-434-7223, or by FAX at 202-783-8750.

SUPPLEMENTARY INFORMATION:

I. Background

Through lectures and panel discussions, participants will learn from senior FDA and industry representatives how the Government and the medical device industry communicate expected and unexpected risks to practitioners, patients, and the general public. FDA will present the results of its recent research on risk communication. Participants will also learn from clinical practitioners, risk managers, patient advocacy organizations, and the news media how this information is received and transmitted to patients and the public. These issues will be discussed, with audience participation, by a core panel comprised of representatives from FDA, industry, and academia. Additional information regarding the public meeting agenda is available on the Internet at http://www.advamed.org/​publicdocs/​risk_​communication_​wkshp.shtml. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

II. Registration

Those interested in attending may register online at http://www.advamed.org/​publicdocs/​risk_​communication_​wkshp.shtml. You may register online until September 25, 2006; however, onsite registration will be permitted if space remains. There is a $350 registration fee to attend the meeting. Please submit registration early in order to reserve a space, as space is limited. If you require special accommodations due to a disability, please contact Margaret Tolbert (see FOR FURTHER INFORMATION CONTACT) or the Marriott North Hotel and Conference Center at 301-822-9200, at least 7 days in advance of the meeting.

Dated: August 31, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.