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.

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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.

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