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FDA 'Open' to 510(k) Proposals

 |  By Margaret@example.com  
   August 01, 2011

In response to a report highly critical of its 510(k) clearance process for certain medical devices, the Food and Drug Administration has announced plans to open a public docket to begin receiving comments on program. The FDA said it will also schedule a public hearing.

In a scorching report released Friday, the Institute of Medicine said the 510 (k) program is an ineffective tool for establishing the safety and effectiveness of moderate risk Class II medical devices such as artificial hips.

Instead of attempting to modify the program, the IOM wants the FDA to scrap it and develop a new framework for review that "integrates pre-market clearance and post-market performance to assure the safety and effectiveness of a medical device through its life cycle."

The FDA, which commissioned the IOM report in September 2009, noted in a statement that the IOM's recommendations are nonbinding. "FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Critics have long called for changes in the 510(k) program, which reviews about 4,000 applications each year, to bring medical device review in line with the strict standards applied to new drug releases. The FDA proposed in January its own plan to change 510 (k) but was criticized then for deferring any consideration of creating a subset of Class II medical devices that would require a more rigorous review than other devices in the class.

In assessing the 510 (k) program the IOM took particular issue with the "substantial equivalence" standard, which by law permits the FDA to clear for marketing a medical device that is similar to any previously cleared 510 (k) device. According to the report, the FDA doesn't require evidence that the new device is safe and effective and instead assumes that it meets that standard based on its similarity to another approved device.

"The 501 (k) program can't be transformed as long as that standard is used," said David Challoner at the press conference announcing the release of the report. Challoner, who chaired the IOM report committee, challenged the FDA to be forward-thinking. "A system was put in place 35 years ago that does not really assess safety and effectiveness. We need something different for the next 35 years. We're dealing with a whole new world: new technology, new materials and new data."

The committee recommended that any new medical device review framework considered by the FDA should:

  • Be based on sound science;
  • Be clear, predictable, straightforward, and fair;
  • Be self-sustaining and self-improving;
  • Facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
  • Use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness;
  • Be risk-based.

Interest groups were quick to side with the FDA. Among the criticism: changes in the 510 (k) program would require Congress to act and that would slow the introduction of new medical devices to the market.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association, which represents medical device companies, said "The report's conclusions do not deserve serious consideration from the Congress or the administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven, and unspecified new legal structure. This would be a disservice to patients and the public health."

The Medical Device Manufacturers Association released a statement saying "MDMA will continue to closely examine this report, though we completely disagree that the 510(k) pathway is flawed and that the FDA needs to eliminate it…it is also important to remember that studies prove the 510(k) process has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted."

The consumer advocacy group Public Citizen applauded the IOM findings. "The FDA should accept the IOM's recommendations, abandon efforts to salvage the 510(k) process that are doomed to fail, and quickly move forward with developing and implementing a new, more robust regulatory framework for clearing medical devices that will protect the public health.

Public Citizen's health research group for years has asserted that the FDA's procedures for clearing medical devices under the 510(k) process are flawed and fail to adequately protect public health."

Challoner rebuffed suggestions that existing regulations already thwart medical device innovation and that the IOM recommendations will only make the situation more difficult. "There is no way of assessing, based on a review of available evidence, whether current regulations are having either a positive or a negative effect on innovation. He suggested that the FDA commission to review the issue.

For its part, the FDA said it already has underway efforts to incorporate some of the IOM findings to strengthen the 510 (k) process, including clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrant a new 510(k) submission.

Margaret Dick Tocknell is a reporter/editor with HealthLeaders Media.
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