Medical Device Daily Washington Editor

Clinical lab operators are sometimes no more happy than those making medical devices about the regulatory burden imposed by FDA and CMS, although those burdens are substantially different. So when the director of the division of lab services at the Centers for Medicare & Medicaid Services told attendees at this week's annual meeting of the American Association for Clinical Chemistry (Washington) that the agency would rethink its expectations for lab quality control, the news was at least not the object of lusty boos and catcalls.

Judy Yost, the director of the division of lab services at the Centers for Medicare & Medicaid Services, titled her talk "New Methods for Complying with QC," and started out by reminding lab operators that as of last December, there were more than 200,000 labs operating in the U.S., which she described as "an astounding number." While only about 36,000 of that total are subject to lab QC, the task of keeping track of them is still no cakewalk.

CMS has been rethinking lab QC, Yost said, adding, "we have a lot of reasons we thought new QC was necessary," including the advent of new technology "and so much more testing being done in point-of-care settings."

Yost said the idea of "equivalent QC" – which would not apply to waived settings – first appeared in the interpretive guidelines published by the agency in 2004, which she said was "a welcome addition" for many labs. At present, QC requirements include a verification of the manufacturer's performance specification as well as establishment of performance specifications for lab-developed, or home-brewed, tests. Calibration is another feature of lab QC, as are daily quality control checks using two levels of external control materials. Those controls can be obtained from providers or made in-house, and can also be drawn from previously tested patient specimens.

CMS is offering three equivalent QC (EQC) options to the traditional QC regime. For instance, analytical equipment that has internal monitoring systems for all analytical components can scale back their QC tests with external controls to once per calendar month with two levels of controls if that system can go 10 consecutive days under daily without going out of spec. The other two options address systems with some internal analytic controls and those with none, all with the idea that tests can be scaled back so long as the lab can demonstrate that the systems behave in a stable fashion.

However, Yost noted that "labs will need more information from manufacturers" regarding the internal controls, and warned attendees that "one-size-fits-all won't work for all test systems."

X Spine nets 12-count warning

The July 15 warning letter addressed to X Spine (Miamisburg, Ohio), may or may not have represented an improvement over the form 483 the firm received at the conclusion of the April inspection of the firm's facility, but the 12 citations dotting the letter ranged from medical device reporting (MDR) systems violations to design control problems.

As is often the case with warning letters, the firm's use of a contract manufacturer was cited as a source of regulatory grief as well.

According to FDA, X Spine had not "established quality requirements for your suppliers/manufacturers of implantable devices and instruments," noting that the agency's investigator saw no contracts or agreements that stipulated that the contractor inform X Spine of any intended changes to design or manufacturing specifications. The firm's proposed corrections drew no critique, but FDA asked for corroborating documentation.

FDA said that the company also failed to evaluate a contractor who handled the steam sterilization validation studies for two of the firm's products "to ensure they could conduct the validation studies in accordance with the specified standard." The agency noted only that X Spine indicated it had revised its supplier approval procedure to cover this requirement.

The company also drew fire from FDA for failing to approve a design plan for the Spider cervical plating system until after the devices were already in distribution and for "failure to address sterilization requirements in the design inputs." FDA asked for an update to these and other citations under design controls.

David Kirschman, the company's president, told Medical Device Daily that this was a documentation issue and there was no question of a problem with the products themselves. "We're working diligently with FDA to address the issues," he said.

Senators back FDA tobacco bill

Despite warnings that FDA is still not fully funded for its current mission, the House of Representatives voted Wednesday to give FDA the power to regulate tobacco products, and two members of the Senate – one Democrat and one Republican – indicated their support for the idea.

The House vote produced an overwhelming margin of 326 to 102, but the GOP vote was almost evenly split at 96 in support and 99 against. Only three Democrats voted against the bill vs. the 230 who voted aye, and the bill found the backing of tobacco giant Philip Morris USA (Richmond, Virginia), whose support fed suspicions on the part of anti-smoking lobbyists. The bill does not permit FDA to ban the presence of nicotine, but does give the agency the authority to reduce nicotine to non-addictive levels.

In a July 31 statement, Sens. Ted Kennedy (D-Massachusetts) and John Cornyn (R-Texas), applauded the House vote, with Kennedy characterizing the vote as "a major step forward," according to Kennedy's spokeswoman, Melissa Wagoner. Cornyn said for the record that the bill would "equip the FDA with the authority and resources necessary to take real, tangible steps to prevent tobacco manufacturers from targeting young people and from misleading the public about the dangers of smoking."

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