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This article was originally published in The Gray Sheet

Executive Summary

ODE BEEFING UP REVIEW STAFF AT GENERAL/RESTORATIVE DEVICES DIVISION, the diagnostic and surgical devices branch of the division of ophthalmic devices, and the gastroenterology and renal devices branch of the division of reproductive, abdominal, ear/nose/throat, and radiological devices, according to Alan Andersen, PhD, acting director of the device center's office of device evaluation. Addressing the annual meeting of the Health Industry Manufacturers Association on March 31, Andersen said that an expected 10% to 15% increase in ODE reviewers would be targeted to those divisions that are viewed by the center as the "areas of most concern." "Those of you who have stuff in the pipeline in the ophthalmic area, in the surgical group, start smiling," Andersen said. "The increased resources are clearly going to be targeted into that group, which has had a serious deficiency in terms of internal expertise. We're going to beef it up and start moving to get the decisions through the system." Although Andersen did not specifically mention the gastroenterology branch in his formal remarks to the HIMA gathering, the group is targeted for increased staff as well, according to FDA. Noting the "big discrepancy" between the number of submissions received by the division of general and restorative devices and "the amount of submissions that we're able to process through the system," Andersen said that the center would address that problem, "at least in the short term," with "a significant increase [of] warm bodies in the division working on the review process." The division has become bogged down because of regulatory changes, such as increased requirements for disinfectants, that have been made without concurrent increases in staffing. According to Andersen, during the month of February, the division acted on 135 510(k) applications, which represent approximately one-third of the 510(k) decisions made by all of ODE during the month. The mounting backlog is evidenced by the fact that the division received a total of 244 applications in February. Backlog at the division also was highlighted at the meeting by the device center's new director, Bruce Burlington, MD. Noting that "there are very substantial discrepancies" in workload across the divisions, Burlington reported on March 30 that "almost half the work pending" is in the division of general and restorative devices. "About 40% of the work within that division" is in the general hospital devices branch, which "is only staffed by three people." The "obvious answer," Burlington said, "is we have got to be able to move staff around to meet these needs." Because "you can't automatically exchange a specialist from one area for another," the center will have to "work at finding ways to use people so we both take advantage of their special expertise and provide ourselves with flexibility to meet shifting workload," he noted. Burlington reported that over the last three weeks, the center has received clearance from upper levels of the agency to add 16 reviewers. In addition, Burlington has asked "six or seven" individuals (clinicians and support staff) from the office of health affairs to join ODE. To facilitate shifting reviewers to high-priority areas, ODE is planning to restructure its "benefits" programs to reward reviewers "who can move around," Andersen reported. There "has been a paradigm within the device organization in which you advance by becoming the best and brightest in your particular area," Andersen said, but "the new paradigm is to rather value mobility within the organization." Currently, he explained, "there is not a paradigm that says you get bennies in the organization by being someone...who can be relied upon for your basic...expertise" and who can "move from the area in which you are most comfortable into an area in which there is a significant resource need for your services." Andersen outlined three potential reward mechanisms for such versatile reviewers: ** use of the "honor awards system," which traditionally has recognized individuals who are associated with "major crises" but not "high quality reviewers who are able to handle a lot of different workloads" ** "instant cash awards, which we now have the flexibility to use" ** and promotions. Andersen noted that the current promotion system allows individuals to be elevated to grades 14 and 15 "without having to give up their technical chutzpah and go become a manager someplace." However, "that process unfortunately is very focused on individuals with narrow expertise." FDA "needs to change that...and develop criteria that are more broad-based [so] that somebody who has expertise in a particular area and applies it broadly across a number of devices" can receive that promotion. Outlining other efforts to alleviate the resource crunch at the device center, Burlington noted that ODE is "integrating more of our research staff into the review process" and "using other FDA resources such as scientists from the FDA center for toxicological health to help on problems in their areas of strength." The center is "going to put more emphasis on in-house use of statisticians, not just as reviewers but as educators to heighten our review staff's focus on statistics," Burlington reported. He said that the agency will be putting "our statistical staff in the same building as the reviewers as soon as we can get space, and we will be ramping up training for reviewers in general." An additional step to increase efficiency at ODE is Burlington's plan to "empower" the divisions to make more regulatory decisions. Burlington said he intends to "increase the decisionmaking on the division level" while "switch[ing] to an accountability and audit system for quality control." The center director plans to meet with ODE staff in the near future to discuss what types of authorities should be transferred to the review staff." CDRH also is considering having "administrative nonscientific staff" review "selective" Class I 510(k)s, Burlington said. Andersen elaborated on Burlington's remarks, noting that such reviews would be focused on low-risk devices. "What we're setting up is a system in which at the low end [of risk] we may be able to do simple reviews, maybe even...using...consumer safety officers -- individuals with a lot of experience, with some scientific training, but who can look at the administrative questions that really become the crux of the matter for these low end of complexity devices." The administrative review is part of the center's "triage" plan for prioritizing review of devices ("The Gray Sheet" March 15, p. 3).

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