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of May 1995, 4 percent of the 1989 PMAs were unresolved, and

81 percent of the 1994 PMAs were still in review.  The FDA

is far short of reaching its mandated requirements to com-

plete reviews of 510(k)s in 90 days and PMAs in 180 days.

How Long Does FDA Review Take?

The 1976 law requires the FDA to complete review of

510(k) devices within 90 days and review of PMAs within 180

days.  Those requirements have proved unreachable for the

FDA.

In 1995, at the request of Representative Joe Barton

(R-Tex.), the GAO examined the FDA review times for medical

devices from fiscal year 1989 to May 18, 1995.31  In its

October 1995 report, the GAO found that FDA had failed to

meet the review deadlines.

For 510(k)s:

· The median approval time for 510(k) applications was

222 days for applications submitted in 1993.

· The average for all 510(k)s was even greater, 269

days, and will continue to grow as the remaining open

cases (3 percent) are gradually closed.  If these

outstanding reviews were arbitrarily closed at the cut-

off date for the GAO's data collection, the mean would

jump to 285 days.

For PMAs:

· The median review time for PMAs completed in 1993 was

804 days.  The mean was 591 days for all PMAs over the

1989 through 1993 time period.

· Open or unresolved PMAs, for which reviews were not

complete, ranged from 4 percent of 1989 submissions to

40 percent of 1992 and 1993 submissions and 81 percent

of 1994 submissions.

For PMA Supplementals:

· For PMA Supplementals submitted in fiscal year 1991,

the median review time was 154 days, the mean was 261

days, and 3 percent of the submissions remained open.

· The mean time for review of all PMA Supplementals was