Although the median review time showed a decline in 1994 (152 days), it remained higher than that of the initial 3 years. Of all the applications submitted to FDA to market new devices during the period under review, a little over 90 percent were for 510(k)s. Between 1989 and 1994, the number of 510(k) applications remained relatively stable, ranging from a high of 7,023 in 1989 to a low of 5,774 in 1991. In 1994, 6,446 applications were submitted. For applications determined to be substantially equivalent, non-FDA time—the amount of time FDA placed the application on hold while waiting for additional information—comprised almost 20 percent of the total elapsed time. Premarket Approvals (PMAs)

The trends in review time differed for original PMAs and PMA supplements. In 1993 and 1994, the median declined to 242 and 193 days, respectively. This trend was reflected in the mean review time that peaked at 336 days in 1992. Investigational Device Exemptions (IDEs)

For IDEs, the mean review time between submission and FDA action was 30 days, and it has not changed substantially over time. The following tables present information on review time for PMA applications for fiscal years 1989 through 1995. Original PMA applications are distinguished from PMA supplements. GAO Comments

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Why GAO Did This Study

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.

What GAO Found

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.