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REP. DINGELL'S MEDICAL DEVICE HEARING DELAYED TO FALL AT EARLIEST

This article was originally published in The Gray Sheet

Executive Summary

REP. DINGELL'S MEDICAL DEVICE HEARING DELAYED TO FALL AT EARLIEST, Claudia Beville, a staffer for Rep. John Dingell's (D-Mich.) House Energy and Commerce oversight subcommittee, indicated a March 2 Health Industry Manufacturers Association conference in Washington, D.C. Beville said that the hearing would likely be held about six months after a subcommittee report on FDA's Center for Devices and Radiological Health is released; the report is expected to be issued in March. The hearing had been expected to coincide with the release of the report. However, Beville said that the subcommittee would like to provide the Clinton Administration and new CDRH Director Bruce Burlington a chance to settle in before calling a hearing. "There is so much change going on that it did not really appear to be appropriate to drag in [Burlington] and have him explain the situation when he is trying to get his feet wet," Beville said. The subcommittee report is expected to focus principally on CDRH's office of device evaluation. The subcommittee has been evaluating ODE for over a year, and the report is likely to describe observed weaknesses in the review program, as well as recommendations for improvements. Beville foreshadowed findings of the report at the HIMA meeting, as she has at other recent public appearances ("The Gray Sheet" Feb. 8, p. 5). For example, commenting on the reasons behind ODE's 510(k) backlog, Beville said that "confusing and contradicting messages" are being given to device reviewers. "They are told they are supposed to take science up a notch, but my opinion is they have not been given adequate information on how to incorporate the increased science operationally into the approval process." However, she added that she was glad to hear that CDRH was considering addressing the "crisis of competence among ODE reviewers" by sending them to continuing education programs outside the agency. She added that the subcommittee had found that reviewers "are demoralized by a multitude of factors, including pressure from industry, pressure from the public, pressure from Congress, [and] pressure from their supervisors." At the same time, they have "been told by the commissioner's office that they need not worry about any [approval decision] time limit for making a decision on an application" and that "the commissioner's office will 'take the heat'" for any review delays. Beville also expressed uncertainty over "how seriously the commissioner's office wants to address this backlog issue." She worried that the commissioner's office will use the backlog "to justify user fees" for the device industry. Despite these concerns, Beville acknowledged that CDRH currently is considering several initiatives aimed at improving the efficiency of ODE. In addition to potentially sending reviewers to more educational seminars, the device center has demonstrated an openness "to at least consider the idea of exempting devices that are not critical or have very low risk" from 510(k) requirements or "providing an alternative way of approval without [the application] going through an extensive approval process," Beville said. She called for 510(k) exemptions for Class I and low-risk Class II devices at the Utah International Medical Device Congress in February. Beville also told the HIMA participants that there is "more willingness [at ODE] to adopt the idea of screening applications before filing, kicking back [to manufacturers] incomplete or unacceptable applications." ODE also is receptive "to the idea of developing guidance documents to improve the quality of applications," Beville said. Although the subcommittee's medical device probe currently is focusing on the device review program, it is likely to turn to enforcement issues following completion of the CDRH report, Beville stated. "There are a number of concerns that" the subcommittee has "regarding enforcement activities that are going on both within" CDRH and the Center for Drugs Evaluation and Research. The subcommittee has received "disturbing allegations of unusually harsh -- almost draconian -- actions that the district offices have taken without really an attempted assessment of whether the action was commensurate with the violation," according to Beville. She said a "multitude" of firms have contacted the subcommittee with enforcement complaints.
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