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This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health should abbreviate its review of 510(k)s submitted for "routine and minimal" changes in product design, the House Energy and Commerce oversight subcommittee says in a bipartisan report on CDRH released June 1. The subcommittee, chaired by Rep. John Dingell (D-Mich.), states that minor device modifications "should not require a full- blown review and an extended wait in the approval queue." The report adds: "Part of the growing backlog of 510(k) applications can be attributed to applications being filed for minimal product changes." According to the report, the subcommittee staff and managers at the device center's office of device evaluation have discussed an alternative 510(k) review program under which manufacturers would certify that device changes are "nonsignificant." Certifying applications, "primarily for 'nonsignificant' and incremental changes in Class I and Class II devices," the report says, would "minimize the amount of review" of the submissions. To ensure compliance, the policy "would carry with it a civil penalty for nondisclosure of critical information relating to the safety of the device and might even carry a criminal penalty if the certification was willfully and materially false." Entitled "Less Than the Sum of Its Parts," the report culminates several years of investigation into CDRH by the subcommittee, including the in-depth audit of ODE operations begun over a year ago. The subcommittee is expected to hold a hearing this fall on CDRH and the status of ongoing agency efforts to revamp the device program. Commenting on the report in a June 1 press release, Dingell addressed the center's need for resources as well as reform. "We are well aware that the FDA lacks the resources and personnel it needs to do its job properly, and I will continue my efforts to see that the agency has what it needs. But at the same time, the FDA must also prove that it is better able to manage the resources currently at its disposal." As anticipated, the subcommittee focuses its criticism of CDRH primarily on the device evaluation program. "CDRH has problems at both ends of the approval spectrum: it has approved devices that have safety and effectiveness concerns, yet it also has been slow to approve potentially very beneficial devices," the panel asserts. In addition, the subcommittee complains of enforcement practices that have "demoralized and perplexed the medical device industry" (see story, p. 8). The subcommittee calls the growing backlog of device applications "an immediate and critical problem." FDA "made some, but ultimately too limited, efforts to develop a workable solution to the growing backlog which was identified as early as July 1992 by some of ODE's division managers," the report says. The oversight panel says it found "systemic defects within FDA: excessive delays in the review and approval process of device applications; low morale and productivity among staff within the office of device evaluation; inadequate use of science; poor or nonexistent communications between the device industry and the agency; and organizational flaws that have made the [device] center less than the sum of its parts." In addition to limiting the scope of 510(k) requirements for device modifications, the subcommittee recommends a scaled-down review of 510(k)s for device manufacturing changes. Devices "which may require a review of manufacturing changes, but which do not raise significant questions of safety, should be placed in a separate category from high risk or critical new devices which require closer scientific scrutiny," the subcommittee suggests. "Low risk device applications could be handled as supplemental 510(k)s and/or handled by inspections [of device manufacturing facilities and] subject to central [FDA] review only if necessary." The subcommittee also says that "a number of devices should be reclassified into Class I and, where appropriate, exempted from the requirement to submit a 510(k) application and other requirements." In addition, "devices that are subject to dual regulation may be candidates for regulatory exemption or a shortened review process." The device center "must recognize that their limited resources should be allocated to reviewing critical devices," the subcommittee asserts. "It makes little sense to subject devices that do not impact safety to the same treatment accorded risky devices. The failure to allocate resources where risk is greater draws reviewer resources away from where they should be focused, and overwhelms reviewers with the sheer volume of applications." In a June 2 background document on the report, FDA says it "views the committee's proposals as reasonable and constructive," adding that "the agency has already begun to make many of the suggested reforms." FDA says it is "working to regain the timeliness and predictability of premarket submissions and is making definite progress." The agency notes that it has already approved 17 premarket approval applications this fiscal year, compared to 12 in all of fiscal 1992. "Regaining the timeliness" of 510(k) reviews, however, "continues to be more challenging." Although FDA has not announced an intent to abbreviate the reviews of 510(k)s for minor device design and manufacturing changes, the agency notes in its response to the report that it is shifting more resources to review of higher risk devices through implementation of its "triage" plan ("The Gray Sheet" March 15, p. 3). The triage proposal, expected to be implemented within the next several months, would abbreviate the review of certain low risk devices and devote more resources to evaluation of higher risk products. Additional immediate FDA actions recommended in the report include: creation of a "separate, expedited approval track for [premarket approval applications] for devices that save lives or otherwise offer major health benefits not presently available"; early and frequent communication between manufacturers and FDA regarding design of clinical studies of devices; and establishment of a mechanism to "screen applications before they are filed, and reject those that are incomplete or otherwise obviously not acceptable." FDA has discussed plans to implement changes in these three areas over the past several months ("The Gray Sheet" April 5, p. 1). The agency states in its response to the report that it "will no longer review an application for a new device if it is not reasonably complete and thus worthy of the reviewers' attention" and will "insist on more exacting clinical studies of new devices by meeting with sponsors and consulting on their study protocols before the study begins." The agency has scheduled a conference for Sept. 27-28 that will address the development of guidelines for the design of clinical trials. The report faults the quality of premarket applications submitted to FDA as contributing to the application backlog. Submission of weak applications forces reviewers to spend time requesting and reviewing additional data, the subcommittee notes. "The center and the industry have a choice: either improve the quality of applications so reviewers do not have to spend time processing iteration after iteration of applications, or acquire additional reviewers." The agency also is developing guidance on "what reviewers ought to consider in reviewing device applications," a further subcommittee recommendation. FDA has additional efforts underway to address another of the subcommittee's recommendations -- the development of guidance on the types of device modifications that require a new 510(k) ("The Gray Sheet" March 8, p. 7). "If [the center's office of compliance and surveillance] establishes and adheres to a criteria of only requiring new 510(k) applications when a change is truly significant...the number of backlogged applications should be reduced," the subcommittee states. The subcommittee also urges FDA to press ahead with its calls for PMAs on preamendment Class III devices. The agency "should develop a plan, including a schedule, for reviewing these devices in a reasonable period of time. To the extent additional resources are needed, the FDA should inform Congress." A longer-term recommendation made by the House panel is consideration of "alternative means of device regulation." FDA and "later the Congress" should "examine the methods of device regulation used by other countries." The "broader review could determine if the present statutory framework is adequate, even assuming that the report's recommendations are implemented." The subcommittee suggests: "Experts from industry, academia, and medicine should be brought into such a review." The subcommittee report also addresses industry concern over FDA's use of device clinical utility as a criteria for approval. Manufacturers claim that "the use of such criteria infringes on the practice of medicine," the report notes. Since "ODE is barely able to perform the review presently required by statute, it makes little sense for it to add routinely the burden of assessing clinical" utility, the House panel concludes. Although generally critical of the agency's device evaluation program, the subcommittee says it is "encouraged" by changes being made by the agency. "FDA is aware of significant problems within CDRH, and there have been, and continue to be, changes within the center." The subcommittee highlights the appointment of Bruce Burlington as CDRH director in February and the initiation of "a number of steps to address many of the problems associated with the approval process, as well as organization and management, that have contributed to the current state of affairs." The subcommittee comments that FDA's "willingness to recognize past failings, and to undertake significant reforms, is very encouraging."

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