510(k) AVERAGE TOTAL REVIEW TIME INCREASES 24% TO 126 DAYS IN FISCAL 1992
This article was originally published in The Gray Sheet
510(k) AVERAGE TOTAL REVIEW TIME INCREASES 24% TO 126 DAYS IN FISCAL 1992 (year ended Sept. 30), according to statistics released by the Center for Devices and Radiological Health's office of device evaluation. Average total review time -- the number of days that elapse from the time an application is received by FDA to the time a final decision is made -- was 102 days in FY 1991. Total review time includes the time an application is "on hold" pending sponsor submission of additional information. A different measurement -- average FDA 510(k) review time -- increased 26% to 102 days during FY 1992. FDA review time includes "all increments of time FDA reviewed a 510(k)." In fiscal year 1991, the average 510(k) FDA review time was 81 days. One byproduct of the increased 510(k) review times in FY 1992 was a 9% decline in the number of 510(k) decisions made by the device center during the year. CDRH made substantially equivalent (SE), not substantially equivalent (NSE) or "other" determinations on 4,862 510(k)s in fiscal 1992; in FY 1991, FDA acted on 5,367 510(k)s. FDA made fewer 510(k) decisions as it faced a growing influx of the submissions: the agency received 6,509 510(k)s in fiscal 1992 compared with 5,770 in the previous year. FDA cleared 3,776 510(k)s in fiscal 1992, down 12% from the 4,294 510(k) clearances in FY 1991. During fiscal 1992, NSE decisions were rendered on 130 submissions; 122 510(k)s were deemed to be not substantially equivalent in FY 1991. In FY 1992, decisions on 956 510(k)s fell into the "other" category, which includes actions such as the transfer of the submission to another center. In fiscal 1991, 951 510(k)s were in the "other" category. The slowdown in the 510(k) review program and the increase in the number of submissions both contributed to a backlog of 510(k)s at ODE, with 331 overdue at the end of the fiscal year. Fiscal 1992 is the first year since at least 1987 that CDRH has reported a 510(k) backlog. CDRH considers a 510(k) to be overdue when it has not taken final action on the submission within 90 days. The number of 510(k)s pending (but not necessarily overdue) at the end of the fiscal year also swelled in fiscal 1992. There were 3,951 510(k)s pending at the end of the year; 2,291 were pending at the same time a year ago. Of the applications pending at the end of fiscal 1992, 1,352 were "on hold" until the manufacturer submitted additional data, a 52% increase from the 889 on hold at the end of FY 1991. In December, Claudia Beville, the chief device investigator for Rep. John Dingell's (D-Mich.) House Energy and Commerce oversight subcommittee, expressed concern over the "growing backlog of pending [510(k)] applications" ("The Gray Sheet" Dec. 14, p. 4). In contrast to increasing 510(k) review times, premarket approval application review times decreased during fiscal 1992. The average total elapsed review time for PMAs decreased to 310 days from 633 days in 1991. The average review time for PMAs, which is calculated according to a formula in the agency's PMA reg, dropped from 285 days in fiscal 1991 to 186 days in the last fiscal year. FDA notes that under the PMA reg, "the review clock is reset upon receipt of a major amendment." The review clock "also may be stopped and resumed, but not reset, for minor amendments and other minor actions." The average review time includes "all such increments of review that occurred after the receipt of the last major amendment, if any." Despite the decreased review times for PMAs, the agency approved only 12 PMAs -- a record low. Four PMAs were denied during the year. During FY 1991, FDA approved 27 PMAs, down from 47 in 1990 ("The Gray Sheet" Oct. 19, p. 13). There were no PMA denials in 1990 or 1991. Analysis of the FY 1992 approval trends is available in an internal CDRH document that reviewed the program based on data available on Aug. 21 and projected that 12 PMAs would be approved during the year. The document notes that data regarding the total elapsed time for PMA approvals "are misleading" because "it must be realized that six of these 12 approvals were licensing agreements" that "had no new data to review." The report says that "an opposite potentially misleading situation can be seen in the average total elapsed time" for FY 1991, which was 633 days. FDA says that the 1991 figure is "a possible aberration caused by a relatively few protracted approvals which were included in a relatively small number of total approvals for that year." Average total elapsed time was 415 days in 1990 and 348 days in 1989. Regardless, the relatively speedy approval of such a small number of PMAs in FY 1992 demonstrates that FDA devoted less time to the PMA program than in previous years. FDA's internal document states that "CDRH could have fully reviewed 22 PMAs" if resources had not been diverted by the unusual demands of fiscal 1992. The center estimates that "as much as 14% [22.5 full-time equivalents] of ODE's resources" were consumed by activities such as responding to increased oversight from Capitol Hill, the breast implant controversy, and implementation of the Clinical Laboratory Improvement Amendments of 1988 and the Safe Medical Devices Act of 1990. In the document, CDRH emphasizes its previously stated position that "a better measure of PMA review output" than approvals "is the number of PMA actions," such as making filing, approvable, deficiency and denial decisions. "The number of actions...has remained essentially constant for five years," the report states. PMA actions totaled 332 in fiscal 1992, compared to 364 the prior year and 315 in fiscal 1991. The distribution of PMA actions, however, shifted in fiscal 1992. More actions were taken during the middle stages of the review process (deficiency letters and "other" actions that would delay a final decision), while fewer were taken to initiate review (filing decisions) or conclude review (PMA approvals, approvable letters, not-approvable letters and denials). The device center also notes in the report that the number of approval actions, such as filing and deficiency decisions, per PMA is increasing. Applications approved in fiscal 1987 required "an average of 2.4 approval actions," while those cleared this year required 3.5 actions. "This could be indicative that PMAs are currently going through one additional approval review cycle," the center comments. As with 510(k)s, the numbers of pending PMAs and overdue PMAs are growing. "The total number of PMAs under review at any given time has consistently increased over the last two years," the center states. A total of 164 PMAs were outstanding at the close of fiscal 1992, compared with 135 one year earlier. Of 87 "active" PMAs pending at FDA, 36 were overdue this year, compared with two of 49 in fiscal 1991. Seventy-seven PMAs were "on hold" in the hands of the manufacturer at the end of fiscal 1992; 86 PMAs were in this category at the end of fiscal 1991. The number of pending PMA supplements also is on the upswing. The device center had 485 of the applications pending (of which 98 were overdue) at the end of fiscal 1992, compared with 339 pending and one overdue at the end of fiscal 1991. CDRH received 606 PMA supplements in the latest fiscal year and approved 394. In fiscal 1991, 593 were received and 479 were approved. Average review times and total elapsed times remained relatively stable in FY 1992, with the former dropping to 135 days from 143 in FY 1991 and the latter decreasing to 167 from 175 in FY 1991. The investigational device exemption program is the brightest spot in the ODE review picture. Consistent with previous years, the device center managed to review 98% of original IDEs and 99% of IDE amendments and supplements within the statutory 30-day period. The agency received 228 IDE applications in FY 1992 and approved 68. An additional 129 were not approved, and 17 fell into an "other" category. Sponsors submitted 297 IDE supplements, of which 127 were approved, 92 were denied and 78 were given "other" determinations. "The review of IDEs continues to receive top priority, so their review time has not been adversely affected," CDRH states. "About 23% of ODE's review resources are spent on IDEs and IDE supplements." The much larger 510(k) program consumes 40% of ODE review resources, while the PMA program uses 37%. FDA traditionally releases the device review program statistics in an ODE annual report, which includes analysis of review trends. The FY 1992 stats were released without analysis; the agency has not yet determined whether it will issue an ODE annual report.
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