A proposed overhaul of the U.S. Food and Drug Administration's (FDA) process for approving medical devices is under debate by the medical device industry and consumer advocacy groups.
About 90 percent of medical devices in the U.S. gain clearance under an FDA program called 510(k), which is intended to speed approval for products considered to have a moderate safety risk and to be similar to devices already cleared for sale in the U.S. This is a faster and cheaper way for medical-device makers to get their products to the market.
Revised to Add "Medium-Risk" Products?
The agency is reviewing its safety regulations and has proposed many changes in the approval process for a majority of medical devices, especially the 510(k) program. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said process revisions are needed because the program has not had a major update in over 30 years.
Most contested is a proposal to create a new category of medium-risk products that would require more studies on safety before clearance is granted.
The Advanced Medical Technology Association, or Advamed, is a Washington-based trade group that opposes many of the FDA's proposed changes. A statement released by the organization stated that, while the revisions could increase efficiency and consistency in the review process, they also may reduce investment in start-up companies and delay the delivery of health care products to patients.
Revised to Prove Safety?
However, other groups say the current FDA approval program does not always require enough evidence of safety to ensure that people will not be injured by unsafe medical devices. A doctor at the University of California, San Francisco who is also editor of the Archives of Internal Medicine argued that there is currently a "proliferation" of medical devices used in the U.S. without data to demonstrate that they are safe and effective.
In addition, Public Citizen, a consumer advocacy group, would like the FDA to require clinical studies for all medical devices that are "implantable, life-sustaining or life-supporting" to prevent injury from defective products.
Shuren pointed out that regulation changes may not result in more studies being required from medical-device makers initially. He said those types of changes are currently being considered on a case-by-case basis when it is appropriate and necessary and expects the agency to announce its final changes by the end of 2010.