FDA's Center for Devices and Radiological Health (CDRH) premarket review program met all of its goals for fiscal year 1998 (FY 98), which covers the period of October 1, 1997 to September 30, 1998. The Center, which does not receive any user fees, continued to make improvements over previous years' review of medical devices.
During FY 98, CDRH maintained for the second year in a row a "zero" backlog of premarket approval applications (PMAs) for novel devices, PMA supplements, and 510(k)s, submissions for products similar to others already marketed.
CDRH approved 46 PMAs in FY 98, 11 of which represented important diagnostic or therapeutic advances, and four were Humanitarian Device Exemption (HDE) PMAs for so-called "orphan" devices manufactured for the benefit of fewer than 4,000 patients.
Management initiatives that had been tested in pilots were implemented throughout the Center's premarket review program. Communication with industry continued to improve, with more companies taking advantage of the opportunities to consult with FDA while planning clinical studies.
These factors contributed to further reductions in the Center's review times. The average time from submission to approval for PMAs in FY 98 was 12.4 months, 25% less than the average review time of 16.6 months in FY 97 and 50% less than the average of 25.9 months in FY 96. The median total time to approval in 1998 was just 8.7 months.
This year CDRH had the shortest review time for any substantial number of PMAs in a decade. Of the PMAs approved in the past fiscal year, 33% (15 of 46) were approved in less than 180 days, and 63% (29 of 46) were approved in less than 1 year. Furthermore, 28 of the 46 PMAs were never overdue in any review cycle.
For 510(k) applications, the average total review time was 114 days, an improvement over the average 130 days in FY 97 and 145 days in FY 96. This translates to 59% of 510(k) reviews completed within 90 days, compared to 58% in FY 97 and 50% in FY 96.
The median review time for 510(k)s cleared in FY 98 was 83 days. About 98 percent of medical devices marketed in the United States are 510(k) products, which are similar to already existing devices.
In addition to the new devices cited in the FDA's Report on New Health Care Products in 1998, CDRH approved in FY 98 the following significant PMA products:
Two devices to evaluate an antigen produced by some breast cancer cells. The results of the test are used to determine cancer prognosis of the patient and take appropriate preventive measures.
The complete list of CDRH's 46 PMAs and HDEs approved in FY 98 is as follows:
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