Medical Devices:

FDA Review Times, 1989 Through 1996

HEHS-97-146R: Published: Jun 3, 1997. Publicly Released: Jun 3, 1997.

Additional Materials:


Bernice Steinhardt
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Office of Public Affairs
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Pursuant to a congressional request, GAO provided information on the Food and Drug Administration's medical device review times, focusing the three major types of device submissions: (1) premarket notifications; (2) premarket approval (PMA) applications; and (3) PMA supplements.

GAO noted that: (1) the trends in review times for premarket notifications, original PMAs, and PMA supplements submitted from 1989 through 1996 are strikingly similar; (2) the decrease in review times that began in 1994 continued in 1995 and 1996 for each of these types of submissions; (3) the pattern in review times is consistent with FDA's claims that the increases early in the period reflected a growing backlog of applications and notifications and that the improvements in later years indicated that this backlog had been successfully cleared; (4) at the same time, despite the overall positive trend in these results, it should be noted that between 1995 and 1996 the review time for PMA supplements increased slightly; (5) despite this increase, the median review time for 1996 PMA supplements remains shorter than for those submitted in 1994; and (6) thus, it is not clear whether this is the start of a new trend of increasing review times or a single exception to the overall positive trend seen since 1992.

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