Medical Devices

The Food and Drug Administration (FDA) regulates the manufacture and marketing of medical devices in the United States. Some critics have argued that FDA's review of medical devices is excessively lengthy and can impose inordinate delays in the introduction of new devices into the market. GAO found that FDA review times and trends for medical device applications varied widely between October 1988 through May 1995. For 510(k) applications submitted, the review time remained stable from 1989 to 1991, then rose sharply in 1992 and 1993, before dropping in 1994. For 1994, the median was 152 days. The mean time to a decision was higher--166 days--and this mean will continue to grow as the remaining open cases (13 percent) are completed. The review time trend for original premarket approvals was less clear, in part because a large proportion of applications had yet to be completed. Not all the time that elapsed between an application's submission and its final determination was spent under FDA's review process. In many cases, FDA had to wait for additional information.

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.