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This article was originally published in The Gray Sheet

Executive Summary

EXPANDED EXPEDITED REVIEW PROGRAM BEGINS WEEK OF AUG. 2 at FDA device center, according to agency staffers. The device center's office of device evaluation has begun screening incoming premarket approval applications and 510(k)s to determine which submissions meet the recently broadened criteria for expedited review. The new policy, which allows expedited review for a broader range of disease conditions and device breakthroughs, is expected to affect 25-50% of PMAs and a smaller number of 510(k)s ("The Gray Sheet" July 5, p. 4). The Center for Devices and Radiological Health also plans to apply the expanded expedited review policy to pending applications. CDRH is developing a program to have reviewers screen pending submissions and hopes to begin the process in several weeks. Bruce Burlington, the director of CDRH, said the center was considering applying the new expedited review policy, as well as "triage" and "refuse to accept" policies, to pending applications when the initiatives were unveiled in late June ("The Gray Sheet" July 5, p. 2). The device center also began its refuse-to-accept policy for 510(k)s and investigational device exemptions throughout ODE the week of Aug. 2. Implementation followed several days of "intensive" reviewer training on use of the acceptance checklists. Under the policy, FDA is returning 510(k)s and IDEs to manufacturers if the submissions do not meet minimum acceptance criteria spelled out in reviewer checklists. ODE began piloting the refuse-to-accept 510(k) checklist June 15 at the division of reproductive, abdominal, ear nose throat, and radiological devices. In the pilot phase, roughly 33% of 510(k)s were returned to manufacturers as inadequate. In its early stages, the policy is likely to produce a similar rejection rate in all ODE divisions, according to device center staffers. The rate will drop, CDRHers predict, as companies learn what is expected in terms of minimum acceptance criteria. The refuse-to-accept policy should quickly help to reduce the backlog of pending 510(k)s at the device center by lowering the number of incoming submissions. The 510(k) non-approval policy implemented July 23 also should have an effect by reducing the number of pending applications ("The Gray Sheet" Aug. 2, p. 1). As of June 30, the device center's backlog of pending 510(k)s stood at 5,241 submissions, up from 5,015 in May. The backlog of active overdue 510(k)s (those under FDA review for more than 90 days) was 1,697 at the end of June, climbing from 1,569 in May. The 510(k) logjam has continued to grow since June 30, the most recent date for which CDRH has statistics, according to device center staffers. Review times for premarket notification submissions also continue to rise. Total 510(k) review time (the total number of days a 510(k) is pending at FDA) averaged 221 days for June, up from 217 days in May. Similarly, average FDA review time, which represents the total number of days FDA spends reviewing a submission and does not include time an application spends "on hold," rose to 184 days in May and 189 days in June. FDA's backlog of active overdue 510(k)s has grown from 713 in November 1992; a total of roughly 4,300 510(k)s were pending at the agency at that time ("The Gray Sheet" Jan. 25, p. 5). Total 510(k) review time averaged 175 days in November 1992, while average FDA review time was 141 days.

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