A commitment by the Food and Drug Administration (FDA) to require a more stringent approval process for high-risk medical devices remains unfulfilled, said the Government Accountability Office (GAO) in a report presented in an April 13 hearing of the Senate Special Committee on Aging (http://1.usa.gov/hB8QDG).
The GAO had previously reported that the FDA should take steps to ensure that high-risk devices undergo the most stringent premarket review process (http://1.usa.gov/jQlfL5). The FDA has issued a final rule for only 1 type of high-risk device, the GAO testified at the hearing. The remaining 26 types of high-risk devices, such as automated external defibrillators and implantable hip joints, can still enter the US market through a less stringent process.
Mitka M. Device Approval. JAMA. 2011;305(22):2280. doi:10.1001/jama.2011.776