By Margarita Snegireva. The U.S. Food and Drug Administration does not inspect U.S. plants that produce high-risk medical devices as often as it is necessary and checks few manufacturing sites overseas.
The limited device inspections were a symptom of an overall lack of adequate funding that has stretched all parts of the agency, witnesses and lawmakers said at a hearing.
"Americans depend on FDA to ensure the safety and effectiveness of medical products, including medical devices, manufactured throughout the world. However, our findings regarding inspections of medical device manufacturers indicate weaknesses," Marcia Crosse, director of health care at the GAO, told a House Energy and Commerce subcommittee.
The Food and Drug Administration ( FDA ) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.