Medical Device Daily Washington Editor

Device makers can reasonably expect to feel the pressure from a Congress bent on bearing down on the device industry on a number of fronts, but the relationship between industry and Congress — and as a result, between FDA and Congress — may grow more complicated depending on the content of a report expected next week by the Government Accountability Office on FDA's clearance process for medical devices. The report was mandated by the FDA Amendments Act of 2007, which Congress passed as part of its reauthorization of the agency's budget.

The impending release of the GAO report already has drawn the attention of both mainstream and specialty media. An article appearing at the web site for mentions the upcoming GAO report, but also offers some interesting perspectives on how FDA regulates medical devices. The article states that FDA "itself admits that it doesn't feel the need to either establish that medical devices are actually beneficial, or compare them to existing treatments."

The author of the article, Anne Zieger, goes on to say that the only thing FDA bothers with is to "make sure that each device performs the tasks it says it's supposed to (without checking on whether it has a therapeutic effect) and doesn't offer any obvious dangers to the patient." At no point in the article is any distinction drawn between 510(k) devices and pre-market approval (PMA) devices.

A link provided by the FierceHealthcare article makes clear that the New York Times also is pitching in, with an Oct. 27 article on the MammoSite breast cancer therapy as the focus. The article, written by Reed Abelson, uses the case of Karen Medlock, who was referred by her doctor to a center in Oakland, California, for treatment with MammoSite, a therapeutic approach from Cytyc (Marlborough, Massachusetts) for post-surgical treatment to prevent recurrence of the tumor.

The article states that the MammoSite procedure "has been performed on about 45,000 breast cancer patients in this country since the Food and Drug Administration cleared it for use in 2002," but Abelson nonetheless describes the therapy as "highly experimental." The article also describes MammoSite's approval via the 510(k) process as a "fast-track" procedure and neglects to note that the predicate therapeutic regime has been in use since 1991.

The content of the GAO report is difficult to predict, but the agency initially was required to have published it in September. Given the tone of Congress toward FDA and the device industry in recent years, it seems likely that the report will provide further fodder for opponents of the agency and the device industry on Capitol Hill unless the GAO report fully endorses the 510(k) regime.

GHTF forges ahead on inspection

The Global Harmonization Task Force slogs ahead on its task of harmonizing the various regulatory regimes covering medical devices (Medical Device Daily, March 27, 2008), and GHTF has published another document toward that end. This document details the general requirements for audits of quality management systems.

According to GHTF, auditing organizations should emphasize impartiality, which means that any auditing entities should ideally have no stake in manufacturing in any way, but also should not be involved in the design of the quality systems that are subject to the audit. Another potential source of conflict is an auditor with financial holdings in a competitor firm's finances.

On the other hand, "having relationships [with the audited or competitor entities] does not necessarily present the auditing organization with a conflict of interest" so long as that organization can "demonstrate how it eliminates or minimizes" these potential conflicts.

The document, which runs to 36 pages, also recommends that any non-governmental organization involved in the conduct of audits "shall have adequate arrangements to cover liabilities arising from its operations" and should be able to "demonstrate that commercial, financial or other pressures doe not compromise its impartiality."

GHTF's view of the scope of an audit is that an initial audit should cover all aspects of the plant's operation, but that subsequent audits, described as surveillance audits, "should be conducted annually." The document tacitly acknowledges this might be optimistic and states that the interval between surveillance audits "should not be greater than three years and in the case of high-risk devices, no greater than two years."

A surveillance audit does not have to be exhaustive, GHTF states, but a plant should go through an exhaustive audit at least once every five years.

A special audit, the description of which comes across as roughly parallel to a for-cause audit, can be prompted by a change in corporate ownership, according to the GHTF document. Other triggers for a special audit include post-market surveillance data that hint at quality control problems.

As for prior warning before audits, GHTF is cryptic. The document states that when "permitted by the regulatory requirements, the auditee should be notified in advance that an audit is to be conducted," but gives no specifics as to how far in advanced the auditee should be notified. On the other hand, the GHTF document also states, "an unannounced audit may be necessary if the auditing organization has justifiable concerns about implementation of corrective actions or compliance with regulatory requirements.

Guidance needed for amyloid PET trials

Alzheimer's disease is of intense interest and a meeting last week of the peripheral and central nervous system drugs advisory committee wrapped up with the conclusion that imaging agents that are currently under development could help doctors detect the amyloid plaques that are associated with the condition. However, the agency may want to write a guidance specifically for the required clinical trials.

A number of news service reports indicate that Rafel Rieves, director of FDA's office of medical imaging, said at the advisory panel meeting that the agency is interested in writing a guidance for clinical trials to that end, but a commercially available product is probably a couple of years off because no studies are currently under way. Such products would be used in conjunction with positron-emission tomography scans, which can rule out other sources of cognitive dementia, but which cannot at this time pick up amyloid plaque.

Larry Goldstein, PhD, the panel's acting chairman and a professor of medicine at Duke University Medical Center (Durham, North Carolina), is quoted as sayintg that such an imaging agent would be "potentially a powerful tool" but will "require a lot more research."