Medical Devices:

FDA Review Time

PEMD-96-2: Published: Oct 30, 1995. Publicly Released: Nov 9, 1995.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) review of medical devices, focusing on how FDA review time has changed from fiscal year 1989 to May 18, 1995.

GAO found that: (1) FDA review times for medical device applications remained stable from 1989 to 1991, increased sharply in 1992 and 1993, and dropped in 1994; (2) in 1994, the median review time for 510(k) applications was 152 days, which was higher than the median review time during 1989 through 1991; (3) the review time trend for original premarket approval (PMA) applications was unclear because many applications remained open; (4) the median review time for original PMA applications peaked at 984 days in 1992; (5) the review time trend for supplementary PMA applications fluctuated slightly in the first 3 years, peaked in 1992, and declined to 193 days in 1994; (6) in many instances, FDA placed 501(k) applications on hold while waiting for additional information, which comprised almost 20 percent of its total elapsed review time; and (7) the mean review time for investigational device exemptions was 30 days.

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