More openness promised

FDA Launches Medical Device Transparency Website

April 20, 2010
by Brendon Nafziger, DOTmed News Associate Editor
As part of the open government initiative, the U.S. Food and Drug Administration launched a "transparency" website for its medical and radiological devices branch, the agency announced on Monday.

"The new Web site is part of an ongoing effort within FDA to enhance communication and transparency," writes transparency initiative coordinator Afia Asamoah on the FDA's blog.

The Center for Devices and Radiological Health (CDRH) Website will provide a searchable database for information about medical devices both before and after their clearance by the agency; memos from FDA workers about why they've reached their decisions about specific products; information about clinical studies; actions taken by the agency on companies falling afoul of its rules; and a step-by-step guide to makers of radiation-emitting devices on how to navigate the approval process. It will also provide additional educational resources.

"The Center for Devices and Radiological Health Transparency Website gives the public a window into our work," said Jeffrey Shuren, M.D., the director of the CDRH, in a statement. "It provides a closer and clearer look at what we do and why we do it."

The FDA's transparency initiative dates to June 2009, when Margaret Hamburg, the incoming commissioner, created an internal task force to figure out how to make the FDA's workings more transparent to the public. The initiative is part of the broader Open Government Initiative, launched by President Obama on his first full day of office, according to the FDA. The goal is to achieve an "unprecedented level of openness in government."

The CDRH Transparency Web site can be found here: