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Relaxing the Rules?

Proposed changes to Food and Drug Administration regulations could ease approval rules for Orange County medical device makers.

But not everyone can agree on what those regulations should look like.

The FDA recently released a report that contained more than 70 proposed changes to its 510 (k) medical device clearance program for approving devices similar to those already on the market.

The changes, which could lead to speedier device approvals, are being debated by the FDA, device maker lobbyists and a third-party institute.

About 3,000 medical device applications per year, or a majority of those submitted to the FDA, are evaluated through 510 (k). The process can cost device makers from less than $1 million up to $50 million.

Some of the proposed changes include:

• Creating a subset of moderately risky medical devices, such as infusion pumps that are used to deliver drugs and fluids to patients, which would require more safety data included in their approval submissions.

• Streamlining applications for devices that don’t resemble earlier ones and won’t require human clinical trials because their safety risks are low.

• Creating a database that would offer the public access to FDA review decisions and device labeling.

• Forming a science council made up of FDA reviewers and managers to assure quality and consistency over some tougher device science questions. That council is headed by William Maisel, a Boston-area doctor who criticized the FDA’s oversight and urged more consumer safeguards.

“Our intent here is to truly strengthen the program and to strike the right balance,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, which oversees the program. “It’s hard to satisfy so many different interests.”

The FDA still is taking public comments on the changes, Shuren said. That process will include a public hearing on Oct. 7 in Irvine.

“Based upon the public comment, we’ll decide which of those recommendations we may adopt in their current form or a modified form,” Shuren said.

Some device makers have been critical of 510 (k), saying that it’s riddled with inconsistent requirements as well as approval de-lays.

“Because of the market we’re in with non-invasive devices, some of the regulatory hurdles that are in place are absolutely ridiculous with the FDA,” said James Knape, founder and chief exe-cutive of VQ Ortho-Care, an Irvine maker of knee braces and other orthopedic medical devices that are cleared through 510 (k). “Changes have to happen.”

Other device makers and lobbying groups are offering more measured responses.

“It’s rare for the agency to undertake such a review and we hope it will result in a better 510 (k) approval process,” said James Mazzo, president of Abbott Medical Optics Inc., a Santa Ana-based eye surgical device and contact lens care maker and chair of AdvaMed, a Washington, D.C-based trade group (see story, page 22).

Overall, AdvaMed’s “initial take finds there are both positive proposals and recommendations that cause us concern,” Mazzo said.

Mazzo cited some proposals that would increase the consistency and predictability of 510 (k) through reviewer training and oversight, but he said some other changes could, if implemented wrong, result in delaying patients’ access to devices.

Masimo Corp., an Irvine-based maker of patient monitoring devices, declined to comment on the proposed changes.

Masimo Chief Executive Joe Kiani is the immediate past chairman of the Medi- cal Device Manufacturers Association, a Washington, D.C.-based trade group that primarily represents smaller device makers.

Mark Leahey, the association’s president, said in a release that the FDA’s review was “an important first step.”

Any changes should take into account the “sophistication, complexity, (and) unique nature” of medical device research and development, said Brian Henry, a spokes-man for Minneapolis-based Medtronic Inc., a diversified device maker that employs an estimated 650 people at heart valve operations in Irvine and Santa Ana.

Keep Up with Technology

Regulators ordered a review of 510 (k) about a year ago after lawmakers and consumer advocates alleged that the FDA was not adequately protecting patients.

Existing regulatory processes haven’t kept up with technology, which has disrupted the approval process, according to some.

“My own staff were raising that this was a program created many years ago,” Shuren said. “Over time, technology has changed and become far more complex, and the current iteration of the program was not adequate for the technologies that we were seeing.”

While that could mean faster approvals for some devices, it could slow the process for others.

There were concerns that the quickness of approvals have “led to approval of products that were later found to be risky or were approved without significant clinical evidence,” said Juli Moran, a Costa Mesa-based director in Deloitte Consulting’s life sciences practice.

Some changes already have come down.

Shuren said in April that the FDA would make a major shift in how it evaluated the safety of infusion pumps, which have been linked to more than 56,000 complaints of deaths, injuries and product malfunctions from 2005 to 2009.

Regulators will require companies to provide more data about pump design, more testing in real-life settings similar to how the pumps are used and more reporting of data after the pumps come to market.

External Review

The FDA’s decision to take a wider look at the program came a few months after the Government Accountability Office said the agency should take immediate steps to scrutinize higher-risk devices.

After that report, the FDA said that its decision to clear a knee implant made by a New Jersey device maker, ReGen Biologics Inc., was flawed and influenced by four New Jersey congressmen and former agency commissioner Andrew von Eschenbach.

Besides its own review, the FDA also asked the Institute of Medicine, which is part of the National Academy of Sciences, to conduct an evaluation of the program, according to Shuren.

The institute has wrapped up its public hearings and will release its report, which cost the FDA $1.3 million, in June 2011.

Having the Institute of Medicine review the program allows an “independent third party” to weigh in, according to Shuren.

“We may not be implementing any of their recommendations (until), at the earliest, late 2011,” he said, calling the institute’s efforts “complementary” to the FDA’s.

Meanwhile, Deloitte consultant Moran said that some device makers are starting to tweak certain aspects of their operations in anticipation of any pending FDA changes.

As an example, she said companies are starting to make sure that clinical evidence and product safety data are “recognized and managed” much further back in the beginning of a device’s engineering and development phase so it’s available for regulatory submissions.

Because the Institute of Medicine’s report isn’t due until next year, “it may be at least another year before more clarity is provided in the proposed changes for the riskiest class of devices,” Moran said.

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