"We are committed to working with FDA to identify ways the agency can use its available resources as effectively and efficiently as possible. For example, we believe FDA should better leverage manufacturers' certification to the international quality systems standard ISO 13485 to better target its resources to those facilities that potentially pose the greatest health threat to the American public."

Two GAO Reports Online


The GAO report, which details several high-risk areas under federal government scrutiny, is available at:
http://www.gao.gov/new.items/d09271.pdf

Also read the GAO report on pre-market notification (510(k))activities:
http://www.gao.gov/new.items/d09190.pdf

Regarding the latter, pre-market report, AdvaMed's Janet Trunzo, executive vice president of technology and regulatory affairs, said that the association is "pleased the GAO report clearly supports the effectiveness of FDA's 510(k) premarket review process....AdvaMed agrees with GAO's recommendation regarding the need to make final classification determinations for the small number of Class III 510(k) devices and believes that this small subset of pre-1976 devices should be regulated by the agency commensurate with their risk profile."

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.

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