Medical Device Daily Washington Editor

The April 9 warning letter to IDev Technologies (Houston) revealed once again that where FDA and the quality systems regulations (QSRs) are concerned, details matter quite a bit. FDA noted some problems in the firm's validation studies in animal models for a catheter used for procedures involving the human biliary artery, the Supera, and the time-line of events in connection with the device leave both the agency and the firm looking out of sorts. The inspection, which ran from December 2008 to this past January, showed that IDev had encountered problems with device accessories in early 2007, and these problems apparently were not resolved – not to the agency's satisfaction, anyway – until after the firm obtained a 510(k) for the device (Medical Device Daily, Feb. 4, 2008)

FDA says that the Supera's design validation protocol, while still being worked out in animal models, "did not document the specific user needs and intended uses to be evaluated." This citation also states that IDev's validation work in the two animal protocols "validates the use" of the catheter when used in humans despite not specifically laying out the case for human use.

The firm's response involved a revised validation protocol dated Feb. 18, 2009, which FDA says "does not state whether production devices will be used during design validation," and failed to declare whether the design would have to be revalidated should "discrepancies" arise during the effort. The warning letter adds that IDev released an unspecified number of the catheters in 2007 without documenting "why several known discrepancies did not need to be completely resolved."

The failure to resolve these discrepancies noted in a June 2007 validation test report, FDA states, was the subject of a second citation under the design validation heading. The agency states that the discrepancies include "several occurrences of ratchet joint failures, loose strain relief, and cracked distal handles." The firm is said to have undertaken three corrective actions, none of which was completed until last year.

The corrective action dealing with the ratchet joints is said to have been resolved via a determination by the company that such incidents were "a low risk," obviating the need for further action. FDA charges that the four incidents in question each "prevented deployment of the stent."

As might be expected, the validation problems encountered in the Supera migrated to a citation for corrective and preventive action. FDA also cited the company for failing to maintain exhaustive records in connection with what the agency termed a market withdrawal of the first iteration of the Supera, which was replaced by a second-generation version. IDev's perspective was that the characterization was incorrect and should have been described as an "inventory exchange."

Tim Placek, the company's vice president for regulatory affairs, told Medical Device Daily that IDev is "in contact with the Dallas district office" and that the firm's view is that the issues enumerated in the warning letter arose in the context of "procedural and communications issues."

FDA ponders financial reports for CIs

Clinical trials and relationships between physicians and device makers are two of the knottier issues facing policymakers and regulators, and FDA has republished a proposal to collect data from sponsors regarding their relationships with physicians.

According to the April 22 edition of the Federal Register, FDA will require – assuming the proposal finds its way into routine practice – sponsors of drug and device clinical trials to disclose any financial relations with clinical investigators (CIs) who are not directly employed by the sponsoring firm. The FR notice states that the feedback on the first publication of this proposal included a comment regarding "the definition of 'clinical investigator,'" as well as one comment each on the cost of such disclosure and on the form used to file such reports. Should the agency move forward with the proposal, sponsors would have to maintain records of financial relationships with non-employee CIs for two years.

Reid wants to move on FDA tobacco bill

Those who believe FDA already has a full plate might be inclined to think that the Family Smoking Prevention and Tobacco Control Act of 2009, which would give the agency regulatory powers over tobacco, is a bridge too far for the agency, but the passage of this bill in the House of Representatives (Medical Device Daily, April 8, 2009) means that the matter falls to the Senate. The upper chamber's majority leader, Sen. Harry Reid (D-Nevada) has indicated that he wants to see the bill on the Senate floor within the next few weeks.

Opposition in the Senate will come from at least one influential member of the GOP, Sen. Mike Enzi (R-Wyoming) stated recently that he is philosophically opposed to the idea of FDA, an agency tasked with protecting public health, regulating a product that is sure to have profoundly ill effects on health. In a July 2007 statement, Enzi said that such a move would send "a terrible public health message – creating the sense that cigarettes are safe or can be made safer, when we know they cannot."

The bill passed the House 298-112 and may enjoy a filibuster-proof majority in the Senate. However, the bill would not give the agency the authority to ban tobacco products, and some in the cigarette business fear that the support of Philip Morris (Richmond, Virginia) for the bill suggests that the company has its eye on boosting its market power.

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