FDA Not Meeting Device Inspection Requirements

The FDA is not meeting its requirements to inspect high- and medium-risk domestic devicemakers every two years and faces challenges inspecting foreign establishments, according to a new government report.

Instead, the agency inspects higher-risk sites every three years and medium-risk sites every five years, a Government Accountability Office (GAO) report released last month says.

While there is no comparable requirement to inspect foreign establishments, the FDA estimates these facilities are inspected every six years for high-risk devices and every 27 years for medium-risk devices.

The GAO, which interviewed officials from the Center for Devices and Radiological Health and the Office of Regulatory Affairs, says the FDA faces a variety of difficulties managing its inspection of foreign medical device manufacturers. These include challenges recruiting investigators to travel to certain countries and extending trips when inspections reveal problems.

Another problem mentioned relates to IT. The databases that provide information on the number of foreign sites manufacturing devices for the U.S. contain inaccuracies, creating disparate estimates of those numbers.

The report came out the day Congress held a hearing on whether the FDA is capable of doing its job to protect the public due to problems such as insufficient resources, low employee morale and outdated IT infrastructure.

The report, “Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections,” can be seen at www.gao.gov/cgi-bin/getrpt?GAO-08-428T.