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This article was originally published in The Gray Sheet

Executive Summary

510(K) EXEMPTIONS FOR ALL CLASS I AND LOW RISK CLASS II DEVICES could help to improve the productivity of FDA's device review process, Claudia Beville, special assistant to the House Energy and Commerce Committee's oversight subcommittee, told participants at the Utah International Medical Device congress on Feb. 4. Beville said that "there does not seem to be a whole lot of utility" in making Class I and non-critical Class II devices go through the premarket notification process. "If they're not critical, if they are not implantable, if the risk is virtually minimal, what is the point of going through this very long process, making the manufacturer wait, making the [FDA] reviewer go through this extensive process?" Beville indicated that eliminating the "scrutinizing" of Class I and low risk Class II devices could make a dent in the "mounting" 510(k) backlog. She continued: "I don't think Congress is going to embrace the concept, but what we are trying to do" in an upcoming subcommittee report on FDA's device program "is to point out that there are advantages to being able to focus on the critical devices," in making "sure that reviewers look at those devices that pose the most substantial risk." As of Jan. 15, FDA had a backlog of 1,060 active overdue 510(k)s, Beville told the conference. The 1,000-plus backlog is up from 703 at the end of November and 331 at the end of fiscal 1992 in September ("The Gray Sheet" Jan. 25, p. 5). In addition to the recommendation regarding 510(k) exemptions, several other suggestions made by Beville at the Utah meeting likely will appear in the subcommittee report, which is slated for release in March. The report, like Beville's Feb. 4 comments, will center on the device premarket review program. Since mid-1992, the slowdown in device approvals has become the focus of the subcommittee's long-range probe of the Center for Devices and Radiological Health. Prior to writing the final draft of the report, the subcommittee staff will conduct an additional round of interviews with office of device evaluation staffers the week of Feb. 8. The subcommittee also has talked with industry representatives and plans to include a section on their perspectives in the report. A hearing is expected to accompany the release of the report. The session will provide new CDRH Director Bruce Burlington (see story, p. 1) with an opportunity to outline his plan to address the slowdown in device approvals. ODE's productivity would improve if it established "quality control procedures" for device reviewers, as well as an "independent review process to deal with disputed decisions within" ODE, Beville said. She suggested a reassessment of "reward or merit systems to encourage reviewers to achieve the highest levels of efficiency possible." Adding a program to "recognize the contributions of outstanding reviewers...may be something to help the morale problem we have been hearing about." She also suggested that ODE reconsider "discretionary" activities that ODE reviewers undertake. "More investment" in training of reviewers and field staff and a "stronger communications policy both within the center and with industry" also is necessary, she asserted. FDA must provide device firms with a "reasonable understanding of expectations," she said, adding that guidance to industry should be "as clear as possible." A reviewer "checklist" is a good way to ensure consistency of reviews, Beville also maintained. The Hill staffer added that FDA needs to follow the recommendation of the Edwards Committee and develop a mission statement. "Although a mission statement is not a panacea for the organizational problems that exist at...the center and ODE, it is reasonable to assume that armed with a clearly articulated mission statement, the agency will be less defensive and vulnerable to criticism and pressure coming from divergent groups, including Congress." At the Feb. 5 session of the Utah meeting, former device center Director James Benson noted that the agency put on hold the mission statement effort it started after the release of the Edwards report. He also pointed out that CDRH has an established mission statement. Beville said that in the near term, the subcommittee will not direct as much attention to FDA's enforcement activities as it will to the review process. Beville's response to a question on the balance of risk and benefits of medical devices provides an indication of why the subcommittee has moved away from focusing on enforcement as it did in its probe of Pfizer's Bjork- Shiley valve. "I have to say quite honestly that it has been an educational process for me to come to grips with" the risk/benefit issue, Beville said. She noted that she was impressed by the comments of an ODE reviewer who stressed to her that "there are risks associated with every device." She added: "That is not to say that I would go back and necessarily refute all the work that I have done in the past -- the Shiley heart valve and issues like that...[but] we can't forget that there may be people who are being denied appropriate health care" if there is not a justification to withhold the approval of a device with benefits that outweigh its risks. Beville did make a few enforcement-related suggestions, including recommending that district offices establish quality control systems "to ensure" that interpretations of the law "are as consistent as possible as well as fair and reasonable." With the quality control system in place, "only exceptional" enforcement cases arising from field activities "should be referred to headquarters." Beville also applauded the letter sent recently by CDRH Office of Compliance and Surveillance Director Ron Johnson to device companies to explain OCS policies ("The Gray Sheet" Feb. 1, In Brief). She maintained, however, that "it was a first step." Additional letters should explain topics such as the policy on warning letters, she asserted.

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