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This article was originally published in The Gray Sheet

Executive Summary

A device submission "triage" proposal under consideration at the Center for Devices and Radiological Health would streamline review of low-risk, Class I 510(k) devices and increase the stringency of review for higher-risk 510(k)s, according to device center staffers. To simplify the review of low-risk 510(k)s, the device center's office of device evaluation would review product labeling to determine whether the manufacturer is proposing a new intended use for the device. If no new intended use is being proposed, the 510(k) would be cleared immediately, without regard to the "first in, first reviewed" policy currently in practice at the device center. The submission would receive a more extensive review if clearance for a new intended use was being sought. In addition to easing review of some Class I 510(k)s, the proposal also is likely to exempt some low-risk devices from 510(k) requirements, according to FDAers. Members of industry and Congress have been urging more 510(k) exemptions as one way to help reduce the backlog of pending 510(k)s at ODE ("The Gray Sheet" March 8, p. 6). The "triage" of submissions also would mean an increase in review stringency for higher-risk 510(k)s, such as those for preamendment Class III devices. The "triage" proposal is part of a "management initiative" under development at CDRH that is intended to improve submission review times and reduce the backlog of overdue 510(k)s. CDRH expects to flesh out and implement the proposal later this year, according to device center staffers. The plan must be approved at the Commissioner's level, and also will be submitted to key members of Congress, such as Rep. John Dingell (D-Mich.), for their review. CDRH expects that stratifying the review of 510(k)s will save resources as well as reduce the 510(k) backlog. Resources gleaned from the 510(k) program would be applied to evaluation of premarket approval applications, which the device center would like to make a higher review priority. In particular, additional resources would be targeted to PMAs for "breakthrough" technologies. Currently, investigational device exemptions receive highest priority, followed by 510(k)s and then PMAs. Devoting more resources to PMAs was discussed by ODE Director Alan Andersen at a Regulatory Affairs Professionals Society meeting in November 1992 ("The Gray Sheet" Nov. 9, I&W-1). The package of proposals under development also includes expansion of the device center's use of "quality thresholds" for the filing of applications. Currently, minimum acceptance standards are used only for clinical data in PMAs. CDRH plans to apply quality threshold standards to other aspects of PMAs and also to 510(k)s and IDEs ("The Gray Sheet" Nov. 9, I&W-2). CDRH managers indicate, however, that improving the efficiency of review programs will not be enough to eliminate problems in the application review program and that additional resources through device user fees are needed. One initiative for which CDRH lacks resources is collaborating with manufacturers in the early stages of study protocol development to ensure that appropriate data is collected, according to FDAers. Early interaction with sponsors, proposed by Andersen at a dental products advisory panel meeting in February, is one of several device evaluation recommendations made in the recently released Temple report ("The Gray Sheet" March 8, p. 4).

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