Medical Device & Diagnostic Industry Magazine
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Originally Published February 2000

Two recent actions show FDA's readiness to accommodate industry concerns.

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Even in these "grassroots regulatory partnership" days, when FDA yields to industry it's apt to do so slowly and inconspicuously. Such was the case again as the old century wound down, when the agency quietly opened a cautious crackdown on medical device reprocessors and told Capitol Hill it should ease up on its statutory expectation of a new registry of clinical research involving devices.

Both steps had been urged by the device industry. The first was meant to counter inroads on sales of FDA-approved single-use products, and the second to minimize leakage of trade-secret information and avoid elevated legal liability.

The quiet regulatory enforcement attention to reprocessors came, unannounced, in the routine release of a 10-page warning letter to Vanguard Medical Concepts, of Lakeland, FL, and its president and CEO, Charles E. Masek. Intended to be an early indicator of new plans for a more-concerted effort in policing medical device reprocessors, the warning letter targeted "serious regulatory problems involving your firm's practice of reprocessing biopsy forceps."

High among these problems, wrote FDA Florida District director Douglas D. Tolen, was Vanguard's failure to validate its cleaning process "with a high degree of assurance as required by 21 CFR 820.75(a)"—the FDA regulation that requires all manufacturers to establish well-documented validation processes when a process cannot be fully verified by subsequent inspection and test.

Not only had Vanguard failed to impress the FDA investigator, but Tolen said that the firm's written response to the inspection was not adequate "because the validation is not complete." And although the Vanguard sterilization system was not prohibited from use in an industrial application, FDA's quality system regulation requires manufacturers to produce a level of sterility assurance that is the same as that required for healthcare settings—a standard that the company's system apparently did not achieve.

While several of Vanguard's detailed responses to additional inspection observations did "appear to be adequate," Tolen wrote, the response that it attempted to assure FDA that the employee most responsible for process validation had received adequate training was also inadequate, since "a copy of the training records was not submitted."

Tolen's letter is part of a broader but indirect FDA response to demands from OEMs and Congress to adopt a tougher posture toward this largely unregulated industry segment—including a call for new premarket submission requirements. Adding to the pressure, the Medical Device Manufacturers Association recently petitioned the agency seeking a ban on reprocessed devices altogether.

According to a high-level FDA enforcement official, the agency will step up its enforcement efforts to raise the level of consciousness as to what is considered acceptable reprocessing. However, many reprocessors are not registered or listed with FDA, which makes the new crackdown more difficult, the official acknowledged.

FDA's other gesture to industry came in an accelerated report to Congress, released at the end of November, that urged deferral of congressional expectations for a medical device clinical research registry or databank until the results of a similar project for pharmaceuticals can be evaluated. The drugs registry will go online this year.

The 90-plus-page report defers to a tidal wave of industry objections provoked by an FDA Modernization Act (FDAMA) provision, inspired by patient and consumer activists, that requires FDA to conduct a feasibility study on whether there should also be a device clinical trials registry accessible to patients and healthcare providers.

A key rationale for the registry proposal was that, given the difficulty some trials have in recruiting adequate numbers of subjects—which can delay new device development—public access via the Internet might boost recruitment. However, the Health Industry Manufacturers Association responded that a special registry may not be necessary because existing Web sites (such as www.centerwatch.com, www.oncolink.com, and www.drkoop.com) already give clinical trials information and are undergoing "constant expansion."

In its report, FDA said other industry commenters on the idea raised potential negative impacts a registry could have on clinical trials. Some manufacturers said that potential subjects could use information in the clinical trials registry inappropriately to obtain access to investigational devices. Device makers, said the report, fear that "prospective patients, having learned of the enrollment criteria from the data bank, might misrepresent themselves to the study coordinator to meet the eligibility criteria. Manufacturers also expressed concern that enrolling such patients could put the subject's health at risk and compromise the study."

Manufacturers were also concerned about trade-secret information leaking from the registry. "Many manufacturers believe that disclosing information, such as a description of the investigational device and indications for use, could jeopardize the development of a new device as well as the company itself," the report noted. It added that commenters from industry also suggested that competitors could copy research ideas obtained from the data bank. FDA recommended that Congress wait until 2001 before deciding if a device clinical trials data bank is necessary. By that time, the agency will have collected information on the usefulness of the drug trials registry.

These are but two coincidental signs of FDA's growing readiness to accommodate industry concerns, even if they aren't labeled as such. Earlier examples included the launch four years ago in Denver of FDA's "grassroots regulatory partnership" initiative with the medical device industry that eventually yielded advance notice of FDA inspections, annotated FDA-483 observations, and close-out letters when FDA is satisfied with a firm's responses to inspectional findings. Since then, numerous other industry-requested reforms have been implemented, either under the auspices of FDA's own internal "reengineering" measures or to satisfy the provisions of FDAMA.

But FDA is not constituted as a cheering squad for industry. It is first and foremost a public safety agency, established to clean up industry abuses in the early 1900s, and that heritage lives on. When it does industry's bidding in the new millennium—as in the two examples cited above—it will do so slowly, partially, and without fanfare.

An FDA inspection found Baxter Healthcare's infusion pump manufacturing process to be out of compliance with the quality system regulation, according to a recently released September 16 warning letter. FDA investigators said they found inadequate corrective and preventive action procedures and a lack of timely reviews by management and others of the company's monthly nonconforming product trend analysis reports. While three letters from Baxter and a face-to-face meeting between company employees and FDA Chicago District officials appear to have corrected Baxter's deficiencies, FDA said it will still need to verify promised corrections by certification from a third-party auditor or another FDA inspection.

New York–based Ortec International asked FDA in November for a humanitarian device exemption (HDE) for its composite cultured skin to treat four skin diseases—epidemolysis bullosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, and erytheme multiforme.

Under FDA regulations, humanitarian use devices (HUDs) are exempt from effectiveness requirements. An approved HDE authorizes marketing of a device for a term of 18 months, with extensions possible at 18-month intervals. If an extension request is not submitted and approved, the product is no longer considered a legally marketed device. Also, an HUD may not be sold for an amount that exceeds the costs of research and development, fabrication, and distribution. It may only be used in facilities that have established a local institutional review board to supervise clinical testing of devices—and then only after the board has approved use of the device to treat or diagnose the specific disease. Labeling for an HUD must state that, although use of the device is authorized by federal law, it is a humanitarian use device and its effectiveness for the specific indication has not been demonstrated.

FDA should not inspect the compliance of device manufacturers with the medical device reporting, device tracking, corrections and removals, registration and listing, and electronic signature regulations unless it has reason to believe that the firms being inspected are not complying with these requirements, HIMA recommended in November comments on an FDA proposal.

In a draft entitled Compliance Program: Inspection of Medical Devices, FDA proposed adding these areas to its new quality system inspection technique (QSIT) program, but HIMA argued that inspection time will increase significantly, placing a greater burden on the agency's already tight resources. A five-month FDA study completed in February 1999 showed that with QSIT an average inspection took 4.7 days. HIMA maintained that the proposed new inspection components would "increase substantially the amount of time for the QSIT inspection" and should instead be treated separately.

HIMA also contended that FDA's criteria for issuing warning letters has too low a threshold and that a letter could be issued for a single major nonconformity with the quality system regulation. It suggested that "FDA use the threshold for issuing warning letters for instances where the inspection documents QS GMP deviations of a significant type or quantity to conclude that there is a reasonable probability that the firm involved will likely produce nonconforming finished devices."

FDA agreed in November to extend the effective date of a November 2 Abbott consent decree to allow users of the company's in vitro diagnostics to continue obtaining the tests from the company until January 10, 2000. The date extension was allowed to give test users more time to find alternative test methods from other manufacturers. The original decree would have stopped Abbott from making and shipping tests within 30 days of the court-approved document.

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