Medical Devices:

FDA Review Times, 1989 Through 1996

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

Additional Materials:

Contact:

Bernice Steinhardt
(202) 512-3000
contact@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

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.

Sep 29, 2016

Sep 28, 2016

Sep 15, 2016

Sep 14, 2016

Sep 12, 2016

Sep 9, 2016

Sep 6, 2016

Looking for more? Browse all our products here