On Tuesday, September 20, 2005, Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health (CDRH), announced a meeting to discuss efforts to reduce unnecessary exposure from radiological sources regulated by FDA. Schultz invited stakeholders [interested parties] to the meeting to be held Oct. 31 - Nov. 1, 2005 in Gaithersburg, Maryland.

DOTmed talked to John McCrohan today, the deputy director of communication, education, and radiation programs for the FDA's Center for Devices and Radiological Health, about the meeting. He said, "This is an important opportunity for healthcare professionals, academicians, and companies to provide input, feedback and comments on the new Radiological Health Program plan. The results of this meeting will help shape how the FDA focuses on pressing radiological health problems and on new and evolving medical radiation systems."

Dr. Schultz had previously announced a new Radiological Health Program plan for CDRH (go to http://www.fda.gov/cdrh/radhlth/initiative.html
for details).

"The plan outlined several broad areas in which CDRH is prepared to invest energy in our continuing efforts to reduce unnecessary exposure to the public and workers from radiation emitting medical devices and consumer/industrial products," Dr. Schultz wrote in a public letter. Areas of focus include appropriate use of equipment standards; monitoring of radiation emitting products manufacture and use; and education of regulators, users and the public. "In order to effectively address the most important issues, we are seeking input from stakeholder organizations on the issues, the priorities that should be attached to these issues, and the opportunities that exist for collaboratively addressing them," he added.

The first day of the meeting will provide an overview of the CDRH Radiological Health Program plan. Stakeholder organizations will also make presentations that day. Day two will include concurrent sessions led by CDRH staff and focusing on standards, monitoring and education.

If you are interested in participating or have questions contact John McCrohan by calling the FDA at 1-888-INFO-FDA (1-888-463-6332). For his e-mail address and the original text of the announcement go to http://www.fda.gov/cdrh/radhlth/meeting-103105.html

More Industry Headlines