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PMA SPONSORS WILL BE NOTIFIED OF APPLICATION STATUS WITHIN 30 DAYS OF PANEL REVIEW, FDA SAYS; 510(K) NSE DECISION RATE CLIMBS TO ESTIMATED 4% IN FY 1993

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application sponsors will be notified of the status of their submissions within 30 days of review by a scientific advisory panel, Susan Alpert, acting director of the device center's Office of Device Evaluation, announced Oct. 5 at the Regulatory Affairs Professionals Society annual conference in Washington, D.C. "Once a panel-track PMA has gone to panel, we are committed to issue the letter, whether it's an approvable, a disapproval, whatever it is, issue that letter, complete, within 30 days of the panel," Alpert pledged. The initiative reflects ODE's desire to "close...PMAs more quickly than [it has] in the past." Once a panel has made a recommendation on a PMA, Alpert explained, ODE will "incorporate that into the FDA review and issue the information" to sponsors. Thus, firms would be able to respond more quickly to areas of concern identified at the panel meeting, enabling the agency to close the application earlier. At an Oct. 6 session of the RAPS meeting, Alpert discussed ODE's plan for the use of staffers from the Office of Science and Technology in the review process ("The Gray Sheet" Aug. 30, p. 3). With the assistance of the OST reviewers, ODE hopes to make a "significant cut" in the 510(k) backlog, Alpert said. ODE topsiders have begun to ask each review division to identify about 25% of their backlog as a preliminary target for the OST staffers. With ODE mentors, the OSTers will work on these portions of the backlog, with the aim of eliminating them by the end of February. The 25% figure is an initial goal, which may be adjusted as the program proceeds. The agency will follow its "first in/first review" policy in choosing the 510(k)s. During the week of Oct. 4, ODE management asked the two divisions with the largest backlog -- the General and Restorative Devices Division and the Division of Reproduction, Abdominal, Ear, Nose and Throat, and Radiological Devices -- to identify the backlog portions they would like OST staffers to work on. The remaining ODE divisions will be phased into the program over the next week or two. At the RAPS meeting, device center staffers also presented an array of statistics on the PMA and 510(k) programs. ODE Associate Director Philip Phillips stressed that although the number of overdue 510(k)s remains high, "there are some 510(k)s going out in less than 90 days." According to FDA figures, the proportion of 510(k) decisions requiring more than 90 days has increased steadily over the last year and has only begun to decline over the past few months. In August 1992, roughly four times as many decisions were made in under 90 days as those made in over 90 days. By February of this year, applications logged out in less than 90 days roughly equalled those that took longer than 90 days. As of June, overdue 510(k)s accounted for nearly three out of four decisions. In July and August, however, the trend began to reverse, with backlogged submissions representing less than two-thirds of decisions. The number of overdue 510(k)s stood at 1,697 in June and had dropped to 1,685 by August ("The Gray Sheet" Sept. 27, I&W-1). Philips reminded the audience that while review times have been rising, FDA has been making decisions on large numbers of applications. "Review times have certainly freaked out a little bit," he said. "But there's still a tremendous amount of decisions that have been made as part of the 510(k) program on a monthly basis." In August, the agency logged out 425 510(k) decisions, compared to a monthly average of 407 decisions during the preceding 12 months. Despite the agency's activity, it has been hard pressed to keep up with the more than 500 510(k) submissions that on average come in each month. Philips also pointed out that the number of 510(k) "supplements," or responses to requests for additional information, has been on the rise over the past three months. Review time for 510(k)s, which overall averaged a total of 196 days in August, has varied across the five ODE divisions, Phillips noted. He singled out for praise the Division of Clinical Laboratory Devices, which he said has done "a very responsible job of trying to meet that 90-day timeframe" for clearing 510(k)s. "So there are certain segments within the office that are still meeting 90 days or are coming very, very close," he said. Like review times, the burden of pending 510(k)s, PMAs and investigational device exemptions varies throughout the divisions. In August 1993, for example, 47% of 510(k)s under review were in ODE's Division of General and Restorative Devices, whereas just over 5% were in the Division of Ophthalmic Devices. However, Phillips pointed out that DOD has the largest PMA workload. Over half of the IDEs under review in August were in the Division of Cardiovascular, Respiratory and Neurological Devices; two divisions did not have any IDEs under review. Phillips projected that the percentage of 510(k)s deemed not substantially equivalent would be "approximately 4%" in FY 1993. "The number of devices that are found [NSE] has in fact been going up," Phillips said. The 510(k) NSE rate stood at 1.8% in FY 1988 and had grown to 3.3% by FY 1992. The device center improved its PMA output to 24 original applications in fiscal 1993. In addition, Phillips said, the PMAs reviewed this past year were in general "a lot more complex." In fiscal 1992, "five out of twelve" approved PMAs were licensing agreements, Phillips noted, which entail only administrative review. In contrast, Phillips believes that only one of the 24 PMAs cleared in FY 1993 was a licensing deal. Although an improvement, the FY 1993 PMA approval rate is still less than the 40-50 PMAs approved annually in the 1980s.
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