Medical Devices:

FDA's Forecasts of Problem Reports and FTEs Under H.R. 4640

PEMD-88-30: Published: Jul 11, 1988. Publicly Released: Aug 11, 1988.

Additional Materials:


Office of Public Affairs
(202) 512-4800

Pursuant to a congressional request, GAO evaluated the Food and Drug Administration's (FDA) methods for estimating the increase in the number of medical device problems that hospitals would report and the number of staff that FDA would need to analyze those reports under proposed legislation.

GAO found that FDA overestimated the number of problem reports and the number of personnel, since it: (1) based its estimates on a nonrepresentative hospital; and (2) did not consider expected decreases in the number of reports and increases in report processing efficiency.

Mar 8, 2018

Feb 20, 2018

Feb 8, 2018

Feb 5, 2018

Jan 30, 2018

Jan 23, 2018

Jan 17, 2018

Jan 16, 2018

Looking for more? Browse all our products here