Medical Devices: Underreporting of Problems, Backlogged Systems, and Weak Statutory Support

GAO evaluated the Food and Drug Administration's (FDA) implementation of the medical device reporting regulation and medical device recalls. GAO found that: (1) since 1985, only about 25 percent of the device manufacturers that FDA expected to report have reported during any given year, but compliance with the regulation could not be accurately determined; (2) the system FDA established to process and analyze problem reports was not adequate to handle the volume and types of reports received; (3) the regulation did not serve its expected purpose of providing FDA with early warning of device problems; and (4) because of existing statutes, FDA was limited in its ability to find out about manufacturers' recalls or initiate its own corrective actions for device problems.