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This article was originally published in The Gray Sheet

Executive Summary

DEVICE CENTER 510(K) REVIEWER "CHECKLISTS" WILL BE DEVELOPED by the agency as a means to focus reviewers on key issues and thereby expedite the review process, Alan Andersen, PhD, acting director of the device center's office of device evaluation, announced at the Health Industry Manufacturers Association's annual meeting on March 31. "We're going to be using rather extensive checklists to focus the attention of reviewers on the issues that we think are important. Of anything I say today, take that message home; this represents a significant change in an environment in which reviewers feel that they have to ask question after question after question of your submission." The checklist process is intended to expedite the review process as well as capture institutional memory on what important issues might be. The current practice whereby reviewers come up with their own questions "can go on endlessly unless they have some guidance, some empowerment, some indemnification that in fact they don't have to ask a question," Andersen observed. The concern, Andersen continued, "is that we capture the best internal thinking about what is important and what is not. That's where the effort is focused right now. There is a great deal of institutional memory, and before too many people like myself jump ship, it would be nice to capture that institutional memory...of which are the right questions to ask for particular categories of devices." Once developed, the checklists would be circulated within ODE and then made available to industry for comment, according to Andersen. Elaborating, Andersen said: "We want to [develop a checklist] internally, share it with all reviewers, make sure that everyone is [listening] to the same piece of music. We want to share it between branches in the same division; heaven forbid that a good idea in one place be exported to another place two doors down the hall. We also want to share it among divisions within device evaluation." That process, Andersen said, "is well under way right now." After the agency has gotten "to the point where we've got stuff that we're comfortable" with, "history says that the best next step is to share it with you folks. We get feedback that way and you get a sense of what the yardstick looks like." The checklist is one of several efforts under way to improve the review process. As part of the agency's "triage" plan for prioritizing the review of devices ("The Gray Sheet" March 15, p. 3), the center also is establishing a 510(k) nonapproval determination (see story, p. 1), and is considering having non- scientific staff review 510(k)s for certain low-risk devices (see story, p. 3) and exempting additional devices from 510(k) requirements. However, Andersen hinted that the number of additional devices that could be exempted from 510(k) requirements might not be very far reaching. "That's an idea that is on the table," Andersen said, but "I don't know how well that's going to work...We've already exempted a lot of devices from 510(k). I think rather more important is going to be doing speedier and simpler reviews of 510(k)s at the low end of the spectrum." Resources saved through abbreviated and/or fewer 510(k) applications are expected to be shifted to the PMA side of review, with particular emphasis on "high priority PMAs." Andersen remarked that while the center has not "spelled out yet what the criteria are going to be for high priority PMAs," it is "clear from the experience on the drug side that you can define rather more important technologies, and what that provides us the benefit of doing is having a justification for shifting the resources in that direction." The rate of PMA approvals has already picked up this fiscal year. So far, the center has approved 11 PMAs and issued approvable letters for an additional 11 devices. "If that keeps up we will have substantial improvement over last years numbers," Andersen said. In fiscal 1992, the center approved a total of 12 PMA applications, which represented a significant decrease from prior years. Andersen is leaving FDA on April 30 to become director of the Cosmetic Ingredient Review Committee, a panel funded by the Cosmetic, Toiletries and Fragrances Association. Commenting on his departure, Andersen said that he is "not going to go out in a whimper. There's been lots of stuff happening in the evaluation area, lots of initiatives that have begun, and I intend in the last few weeks that I have to do what I can to cement the new directions." Many of the initiatives under way have evolved from ideas discussed by Andersen in a November speech ("The Gray Sheet" Nov. 9, I&W-1 and I&W-2). FDA Commissioner David Kessler, MD, told the HIMA, meeting on March 30 that Andersen "has done an absolutely outstanding job as the acting director of the ODE, and under difficult circumstances. Filling his shoes will be one more difficult challenge for us." Kessler also reiterated his support for user fees at the meeting. Noting that FDA will continue to "make the case" for additional funds for the Center for Devices and Radiological Health "through the appropriations process," Kessler said: "I understand that HIMA is against user fees for devices, but I think you all need to understand that this center -- this very important center - - is under stress and somehow we have to come to grips with that."

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