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An MD&DI June 1998 Column

WASHINGTON WRAP-UP

HIMA asks the House Appropriations Committee to stabilize FDA funding from one year to the next.

James G. Dickinson

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As it has done before, although not recently, the medical device industry is coming to FDA's aid on Capitol Hill. In a March 31 statement, the Health Industry Manufacturers Association spoke out against the proposed deep cuts to the budget for the agency's Center for Devices and Radiological Health.

Distracted by the FDA Modernization Act last year, few in industry noticed the 3.4% cut in FDA's fiscal year 1998 device center budget. Addressing the House Appropriations subcommittee on agriculture, rural development, FDA, and related agencies, HIMA showed that industry is watching closely this time. The group argued strongly against the 26.5% budget cut for CDRH proposed to Congress for FY 1999, which begins in October.

The real focus of HIMA's concern is not Congress but the Clinton administration. HIMA's statement called the proposed White House budget cuts "potentially devastating." It urged the subcommittee to "soundly reject" them and to send the message that "deep cuts in the agency's budget authority for medical devices are unacceptable."

One reason the White House may think it can cut FDA's budget so deeply may be the difficulty both the public and industry have in understanding the budget process. The HIMA statement emphasized the challenge of sorting out "the labyrinthine budget documents to ascertain actual levels of funding, particularly for the review functions of the center." Compounding this jumble is a White House proposal to implement $39 million in user fees.

HIMA asked the subcommittee to restore the same level of funding for FDA in FY 1998 as last year. As for FY 1999, HIMA made no explicit recommendation. Its intent, however, could not be plainer: "The size of the reduction being proposed by the Administration translates into drastic staffing cuts and a concomitant increase in review times. We do not believe anyone wants to see the devastating scene of several years ago repeat itself. Patients will suffer if funding is not kept level for the device program."In response to this year's budget cuts, FDA has terminated its device inspection contracts with Colorado, Texas, and California. FDA's contract with California called for 150 inspections over 18 months. According to Stuart Richardson, Jr., chief of the California Health Department's food and drug branch, the loss will cost his department three full-time equivalent (FTE) positions. It will also waste the device expertise the office had acquired.Colorado's state director for human health Tom Messenger said the loss of FDA funds will cost his department 1.5 FTE positions. Colorado's contract called for 30 inspections a year.The Texas Department of Health's device inspection program did not depend on FDA funds, so no positions will be affected. However, Texas will no longer carry out 75 visits and 90 inspections. How many of the inspections canceled in these states subsequently will be carried out by FDA remains to be seen.FDA finalized its 510(k) paradigm document in March. Eligible devices now have two faster gateways for clearance to market: the "special 510(k)" gateway and the "abbreviated 510(k)" gateway.The special 510(k) gateway is open to sponsors seeking CDRH approval of a modification to a predicate device. The sponsor need only submit summaries of its compliance with design controls. The first documents required must identify the risk-analysis methods used and the corresponding verification or validation requirements and acceptance criteria.The other two documents comprise a declaration of conformity. One document should state that verification or validation activities were performed and the criteria were met. The second document should state that the manufacturing facility complies with the design control requirements set out in 21 CFR 820.30 and that records have been kept available for FDA. The paradigm guidance lists several types of modifications FDA thinks will fit well into this procedure. These modifications include changes in energy type, software, and dimensions. The special 510(k) gateway is not an option if the modifications affect the device's intended use or alter its fundamental scientific technology.The second gateway, the abbreviated 510(k), is open to those whose device design—or part of it—fits a device-specific guidance document, an established set of special controls, or one of the consensus standards FDA recognizes.Such consensus standards can be found under section 514 of the new FDA Modernization Act, as listed by CDRH at http://www.fda.gov/ cdrh/.The submission can be as abbreviated as the sponsor wishes. For submissions relying on guidances or special controls, the abbreviated 510(k) is a summary describing how such guidances or controls were used to address the device's risks. For submissions relying on a standard, the abbreviated 510(k) is a declaration of conformity. The paradigm guidance sets out the format for such a declaration. All other design modifications must be covered by the customary data and information.Sponsors may retain an outside firm to assess conformance to design controls for a special 510(k). Similarly, the sponsor can turn to such a firm to assess conformance to a standard for an abbreviated 510(k). In any event, the sponsor signs off on and remains responsible for everything in the submission.A recent FDA policy position "undermines" its own device review reforms, claimed Kshitij Mohan, Baxter International research and technical services corporate vice president. Mohan spoke at a March HIMA annual meeting panel session with CDRH director Bruce Burlington and the center's Office of Device Evaluation director Susan Alpert. The device review reforms began under the CDRH reengineering effort and were codified in the FDA Modernization Act. The FDA policy Mohan cited, which dismisses the preemption of state tort law claims against manufacturers of FDA-approved devices, was published in a proposed rule last December.Mohan, a former ODE director and a former acting CDRH director, complained that the proposed rule "turns us over to a body of people who have very strong motivations to go around suing everybody." Those words opened what seemed to be a lengthy diatribe against the proposed policy.Given no sign that Mohan would stop amplifying his point, Burlington interrupted him by leaping from his chair in the semicircle on the platform. Waving his arms as if to flag down an approaching train, Burlington protested, "Dr. Mohan! You go on!"As the audience's laughter subsided, Burlington continued his rebuke: "It's obvious that you wanted to talk about that, and I think it's all well and good, but it would be inappropriate for either Dr. Alpert or me to try and second-guess the policies formulated or the decisions made for the whole department or by the whole executive branch."Maybe he and Alpert could be "more useful," Burlington suggested, if they just addressed issues they were free to discuss. Not to be stifled so abruptly, Mohan commented that he was "glad to hear that you agree with us on that issue." His words were drowned out in another outburst of laughter and applause, above which Burlington retorted, "It's amazing that some people hear things that were never said!"FDA approved its first product development protocol in March. Revived from the 1976 Medical Device Amendments by CDRH's reengineering initiative, the PDP is an alternative to the premarket approval (PMA) process. U.S. Surgical (Norwalk, CT) will use the PDP to seek clearance for its En-Abl system for treating excessive uterine bleeding. Under the PDP procedure, FDA is committed to approving the device if test results meet criteria established in the protocol.CDRH can't find much data to analyze with regard to refurbishing single-use devices, the center's director Bruce Burlington told HIMA at its annual meeting in Palm Springs on March 14. Despite agitation by OEMs and the association, "there's a striking paucity of hard data" on safety risks, he said. "Hospitals [refurbish] all the time."CDRH has called for adverse experience reports, has started a study with the Walter Reed Hospital on reengineered balloon angioplasty catheters, and has asked industry for regulatory scheme ideas.The medical device mutual recognition agreement (MRA) that FDA signed with the European Union last year is a long way from being useful, leading EU industry expert Alan Howard told HIMA on March 5. The European Union's own Medical Devices Directive is not yet working, the CE mark is becoming a source of dissension among member states, and Europe still has no postmarket surveillance system. Europe must put its directive into place before the United States will benefit from the MRA, Howard said.Copyright ©1998 Medical Device & Diagnostic Industry