Originally Published MDDI December 2001

WASHINGTON WRAP-UP

Although its purview is limited, FDA is paying more attention lately to device advertising that indicates a change in intended use. Manufacturers will be well advised to double-check with their reviewing division before claiming indications not specifically cleared, says the agency.

James G. Dickinson

Reprocessors Get More Time | Reprocessed SUDs Can Have OEM Marks | Feigal Accepts Dispute Panel Vote | Exemptions from MDR | Gliatech's FDA Action Plan

Most medical device advertising comes under the pur-view of the Federal Trade Commission, but increasingly the FDA is asserting its narrower jurisdiction.

According to Deborah Wolf, acting director of the Promotions and Advertising Policy staff at FDA's CDRH, most of the device advertising and promotion problems her office deals with involve a "change in intended use."

Wolf addressed this topic at a Food and Drug Law Institute marketing conference in Washington, DC, on October 17. She said that FDA identifies a change in intended use by reviewing labeling, advertising, oral and written statements, or circumstances surrounding the distribution of a journal article. Lately, she said, CDRH has been examining its interpretation of claims more closely. The center wants to provide more guidance to industry on what constitutes an intended-use claim and how comparative claims should be looked at. "It's an evolving area at the center," Wolf told the conference.

To illustrate, she discussed a recent untitled letter issued to a firm that had a microscope approved for detecting, counting, and classifying certain cells. The claims the company was making for the device were for diagnosis, staging, and prognosis of certain cancers, which was far more specific than the uses that had been cleared. In addition, the company had claimed that the microscope could be used with a number of assays that were not cited in the approval.

The main question that arose between the company and CDRH, Wolf said, was whether the clearance applied only to the limited number of assays cited or whether they were meant to be examples of a broader clearance. She stressed that when such issues arise during a premarket evaluation, companies need to make sure that the review division views a specific claim as an example of a broader use.

A CDRH guidance document was issued in 2000 on general- versus specific-use claims. As Wolf noted, however, it is a complicated matter and the guidance can be rather confusing. The document outlines what the center considers when determining whether a new specific indication is included as part of a device's earlier general claim for substantial equivalence purposes. It also addresses the addition of claims that could trigger the need for a PMA application. She emphasized that the guidance should not be viewed as a substitute for discussions with reviewers on the scope of claims.

Wolf also updated the conference on the center's recent decision to scrap its plans to allow device makers to include in their labeling and promotional materials language indicating that a device has 510(k) clearance. The decision seems to defy the spirit of an FDA Modernization Act provision that repealed a prohibition on such promotional language for devices covered by a PMA or an IDE. While the existing requirements appear to be inconsistent, Wolf said the Center had several reasons for making 510(k)-cleared devices a separate case.

Reprocessors Get More Time

CDRH director David Feigal says FDA will delay until August 14, 2002, the enforcement of certain postmarket requirements for hospital-based single-use device (SUD) reprocessors. In a letter dated September 25, 2001, Feigal told hospital administrators that the enforcement stay will affect requirements for medical device reporting, tracking, corrections and removals, quality systems, and labeling. Requirements for establishment registration and device listing remain unchanged.

FDA investigators will begin inspecting hospital SUD reprocessors "shortly" to verify compliance with all requirements, the letter continued. However, instead of taking traditional enforcement actions against hospital reprocessors for not complying with the stayed requirements, the agency intends to "educate" hospitals on complying with postmarket requirements.

"This policy will remain in effect until August 14, 2002, provided that the hospitals are taking steps to correct the violations noted during the inspections and that the violations do not pose a serious public health risk," Feigal wrote. He emphasized that this revised policy does not apply to third-party reprocessors.

He also stressed that FDA's previously announced policy of actively enforcing registration and device listing requirements for all hospital SUD reprocessors remains unchanged "and will be actively enforced by FDA immediately."

Feigal told the hospital administrators that no changes have been made to the previously announced requirement that they must submit to FDA a PMA or 510(k) application for any Class III or nonexempt Class II or Class I device that they reprocess.

Reprocessed SUDs Can Have OEM Marks

FDA has denied an Association of Disposable Device Manufacturers (ADDM) petition aimed at curbing reuse. The petition asked the agency to require reprocessors of single-use devices to remove original equipment manufacturer (OEM) trademarks from such devices. The ADDM immediately called the denial "legally indefensible."

ADDM filed its petition on March 22, citing strong concerns about the agency's recent decision on labeling requirements for SUD reprocessors. It argued that the current labeling rules are misleading and cause devices to be misbranded. The organization requested that FDA require the OEM trade name be removed from reprocessed SUDs and a series of disclaimers be added to the labeling to counter "misinformation" about the devices.

FDA flatly refused these requests in its denial letter, saying that while it agrees with the group's concerns that an OEM's name on a reprocessed device may render the content misleading, "any potentially misleading implications . . . can and should be remedied by the disclosure of additional information." FDA also said that OEM references on reprocessed devices do not constitute trademark and trade name infringement. In addition, the agency said, there is no rule prohibiting the addition of items to the labeling, only that certain information must be present.

The agency also rejected the organization's request that reprocessed device labeling be required to state that the OEM opposes reprocessing of the device. "An OEM's determination about the fitness of a reprocessor's device is not relevant if a reprocessed device meets [the agency's] safety and effectiveness requirements," FDA said.

ADDM issued a blistering response to FDA's letter in a press release dated September 25. It said that the agency's decision "ignores or avoids the majority of substantive legal issues presented in the ADDM petition, and mischaracterizes the remaining arguments set forth therein." ADDM asserted that, using the logic put forth by the agency's denial, any device manufacturer could imprint another manufacturer's name on its device without fear of misbranding "so long as additional information is provided."

The release criticized FDA for its policies on SUD reprocessing, saying "despite the clear language of the FDA [Modernization] Act, representations to Congress, and implications for patient safety, FDA will twist or bend the Act beyond recognition to avoid enforcing the law in a manner that might halt some reprocessing."

Feigal Accepts Dispute Panel Vote

CDRH director David Feigal has concurred with the vote of his center's first-ever Medical Devices Dispute Resolution Panel meeting, which unanimously recommended approval of a PMA application for Lifecore Biomedical Corp.'s postsurgical adhesion prevention product, Intergel.

In his "letter of concurrence" stating that the application is approvable, Feigal told the Chaska, MN–based company that labeling and the summary of safety and effectiveness need to be finalized before FDA grants final approval.

CDRH had ruled the PMA "not approvable" earlier this year. Shortly thereafter, Lifecore decided to place the product's fate in the hands of the untested dispute resolution panel, which had been established under the 1997 FDA Modernization Act especially to resolve scientific disputes between manufacturers and the agency.

Exemptions from MDR

FDA says device manufacturers can request an exemption from its medical device reporting (MDR) regulations if they want to avoid reporting subsequent adverse events for products undergoing remedial action, according to a September 26 guidance document.

Such exemptions may be granted when manufacturers provide information indicating that additional MDR reports will not provide any new data. Manufacturers that submit a remedial action exemption notification must have met certain criteria, such as filing an initial MDR report and completing a complaint investigation under the quality system regulation.

The guidance can be obtained by visiting CDRH's Web site at http://www.fda.gov/cdrh/osb/guidance/188.html.

Gliatech's FDA Action Plan

Gliatech (Cleveland, OH) has submitted a corrective action plan to FDA for the GMP-troubled facilities that manufacture its scar-inhibiting Adcon-L barrier gel. The plan includes a switch to new packaging for raw materials used for the product and new manufacturing inspection and testing procedures. This action is Gliatech's latest effort to get FDA permission to resume Adcon-L production.

The company's ongoing difficulties with FDA began in October 1999, when the agency issued an import alert on contract-manufactured Adcon-L following an inspection and issuance of a warning letter to its supplier, Medical Contract Manufacturing B.V., located in The Netherlands.

A subsequent inspection found the company's manufacturing of the product to be out of compliance with GMPs. Further difficulties arose when FDA questioned company data and the process used in presenting the data in a supplemental PMA application for the product.

In October 2000, Gliatech withdrew the supplement, but fallout over those data concerns had already prompted Guilford Pharmaceuticals to walk away from a planned merger with Gliatech.

FDA has indicated that the relaunch of Adcon-L is at least partly contingent on the results of an ongoing independent review of Gliatech's magnetic resonance imaging data from a U.S. clinical study.

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