FDA Issues De Novo Draft Guidance for Review; Agency Hopes to Streamline the Process

FDA Issues De Novo Draft Guidance for Review; Agency Hopes to Streamline the Process

The U.S. Food and Drug Administration issued draft guidance on Oct. 3 in an effort to update the de novo review process for certain low- to moderate-risk medical devices. The document offers a new pathway for concurrent submission to the 510(k) and de novo clearance processes.

Originally passed by Congress in 1997, the de novo process was created for noveldevices that fall short of having a “substantially equivalent” device on the market, and thereby unable to be cleared through the 510(k) process. Devices only are considered for the de novo clearance process—which has been underutilized, according to the FDA—after rejection through the 510(k).

The draft guidance outlines a pathway for a concurrent 510(k) and de novo petition without duplicative data requirements. The process could decrease the process time by as much as 90 days, according to the agency, and provides clarity for manufacturers on the suitability of a device for the de novo process.

“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” said Jeffrey E. Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients.”

The guidance outlines two pathways for the de novo process. It can be initiated with a pre-de novo submission” (PDS) or with a 510(k) submission. A PDS is recommended when it is believed there is no predicate for the device and it is considered of low to moderate risk. Otherwise, manufacturers can submit a de novo petition if no substantial equivalent is found through a 510(k) submission. The FDA provided flowcharts on its website to explain the process of both de novo submission processes. The draft guidance is part of a list of 25 items from the FDA’s recent “Plan of Action” toimprove the 510(k) process.

Revision of the de novo process also was included by the Institute of Medicine (IOM) in its highly controversial 510(k) audit. The IOM audit recommended the FDA explore whether a modified version of the de novo process could replace the 510(k) pathway.

“The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared,” according to the IOM. “Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program.”

The FDA is seeking comment on the draft guidance. The public comment period will be open for 90 days after Oct. 3.

AdvaMed Brass Outlines Upcoming Agenda

The medical device industry in an “engine of medical and economic progress,” according to Steve Ubl, CEO of the Washington, D.C.-based Advanced Medical Technology Association (AdvaMed). Medical device bigwigs recently gathered in Washington forAdvaMed 2011 – The MedTech Conference.

There are few at the meeting who would disagree with Ubl’s assessment.

Right now, the news buzz—not just in D.C., but nationwide (particularly during recent Republican primary presidential debates) is the push for new jobs and an economic recovery. The White House has made job creation a priority and current media push, and it was the theme of the recent medtech mix-and-mingle in D.C.Ubl told a press gathering on Sept. 26 that one of the main themes of this fifth annual event is the “value the industry brings with the jobs it creates.”

Ubl, along with AdvaMed Chairman James Mazzo, senior vice president of Abbott Medical Optics Inc., outlined parts of the association’s agenda for the coming year. Ubl and Mazzo framed the discussion in terms of the healthcare gains the industry has helped to achieve.

For example, according to AdvaMed, over the last 20 years mortality rates from heart disease have decreased 50 percent; stroke deaths have dropped 30 percent; and breast cancer mortality is down by

20 percent.

The message from AdvaMed’s leadership to lawmakers is to not hinder that progress.

“I think it is fair to say that our engine is stalling, unless we move forward with some strong, positive action,” Ubl said. Some of that action includes U.S. Food and Drug Administration reform—i.e., medical device review process improvement—and repealing the medical device tax slated to go into

effect in 2013.

At present, the United States accounts for 40 percent of the global medical technology market, creates 400,000 direct jobs and 2 million total jobs, and pays more than 40 percent of the average U.S. wage, but medical technology employment is slowing in the United States, AdvaMed claims. In addition, though the total medical technology trade has increased, the balance of trade in medical technology has decreased in the last 10 years, according to figures presented by the association.

FDA premarket approval for devices now takes years longer than in the European Union, and each additional month working through the PMA process in the United States costs medical device companies hundreds of thousands of dollars.

Ubl said he has been encouraged by the response from the agency and the bipartisan support from government to tackle FDA performance improvement.

“The president of the United States has talked about the need to update the FDA review process in speeches and in an op-ed in The Wall Street Journal,” Ubl said. “There are several initiatives within the White House Office of Science and Technology Policy to ensure that we maintain our leadership. And there’s bipartisan support in the Congress.”

As the agency and industry begin reauthorization discussions for the medical device user fee program that is set to expire next year (the device industry pays fees for device approval that go toward partially funding the FDA), review times and other performance issues certainly will be part of the dialogue.

“We need stable FDA funding,” Ubl acknowledged. “We should have stable resources—any significant cuts to the agency would be counterproductive. We make no secret about our concerns with the device center’s performance and the drag it has put on the industry’s competitiveness. The FDA has acknowledged our concerns and wants to work toward resolution. The collaboration going forward is really key to success.”

Ubl said the user-fee discussions are just beginning. And though his association supports stable, robust funding, simply throwing more resources at the FDA’s Center for Devices and Radiological Health is not a cure-all.

“Increased user fees alone not the answer,” Mazzo said. “I’m not a big believer that you throw money and people at a problem. I believe you first need to identify the problem and then address it correctly. That’s how successful business people run their companies. So just by adding more funding does not address the issues our member companies address. They’re talking about predictability, consistent questioning, and proper training. Those need to be established first. Once those are addressed, the discussion of funding comes after.”

On the issue of the device tax,AdvaMed’s leadership is bullish on efforts to repeal. “We’re heartened by the growing momentum,” Mazzo said. Recent proposed legislation by U.S. Rep. Erik Paulsen’s (R-Minn.) bill has close to 200 co-sponsors, according to Mazzo. A recent study released byAdvaMed claims that the tax could reduce the medical device workforce by more than 10 percent. Ubl also told Medical ProductOutsourcing that AdvaMed has had ongoing discussions with the Internal Revenue Service to clarify some elements of the device tax so companies and devices aren’t double-taxed. For example, at present, the definition of medical device manufacturer is ambiguous. It is possible that a contract manufacturer responsible for the bulk of a device’s production could be taxed along with their client who sells and markets the device. The IRS has been “receptive,” according to Ubl.

Ubl also noted that rather than a discussion of a wholesale repeal of healthcare reform—and he was quick to add that AdvaMed supported several elements of the reform that passed last year—a discussion of corporate tax reform would be a “much more conducive forum.”

AdvaMed representatives have met with the members of Congress’ Joint Select Committee on Deficit Reduction, also known in Washington as the debt “super committee” charged with hacking $1.5 trillion from U.S. deficit.

“We’re meeting with super committee members and are focused on some sectors of our industry that are potentially under discussion—whether it is imaging, DME (durable medical equipment) or clinical labs,” Ubl said. “[These are] sectors of our industry that have taken multiple reductions in recent years, and we are very concerned about these coming under additional scrutiny.

He also said cuts in hospital payments also are a concern.

“Most of our companies are directly involved with hospitals, which have already taken significant reductions in the context of healthcare reform,” Ubl said. “In general, deficit reduction will be with us for the foreseeable future. So from my perspective, if we want to see the path forward away from these types of ‘meat-ax’ cuts, we need to provide incentives for innovation to ensure that we are treating patients moreefficiently and effectively.”

Another Lawmaker Adds Her Voice to the Device Tax Debate

Yet another Capitol Hill lawmaker has come out against the 2.3 percent tax on medical devices. In an opinion column in The Hill newspaper in Washington, D.C., U.S. Rep. Cathy McMorris (R-Wash.) made her case to repeal the tax, which is set to go into effect in 2013. Given the current state of the economy, McMorris said that now is not the time for heavily taxing an industry that’s creating jobs.

“With the markets seesawing and unemployment rising, creating and maintaining jobs remains Americans’ top priority. Spurring job creation in a field that actually improves people’s lives would be doubly beneficial, which is why health innovation remains a top public policy objective,” she wrote. “To maintain America’s leadership and ensure patients have access to cutting-edge technologies, Congress must eliminate the 2.3 percent tax on medical devices scheduled to go into effect in 2013, curb unnecessary regulations and make the [U.S.] Food and Drug Administration more efficient so that innovators can make their life-saving and life-improving devices readily available in the United States.”

McMorris characterized the medical device industry as “a uniquely American success story,” but cautioned that America could “lose its leadership position.”

She said that the House Energy and Commerce Committee’s Health subcommittee is holding “candid” conversations with the FDA, product innovators and patients to assess how Congress can best assist in authorizing the most effective review process possible.

“A lengthy review process is more than a bureaucratic holdup—it results in devastating ramifications for individuals and families,” McMorris wrote. “Many patients have testified that when faced with a medical condition that could turn degenerative or fatal, they were frustrated to discover that life-altering, or even life-saving, treatments were available, but only abroad … Currently, more than 400,000 Americans are employed in the medical technology industry. In 2008, these workers earned $24.6 billion, which breaks down to an average yearly salary of $58,000. These well-paying jobs are jeopardized when patients and healthcare professionals are forced to turn out of necessity to products only available in European and other foreign markets due to an overly lethargic and repetitive FDA review process.”