FDA 'Open' to 510(k) Proposals

Margaret Dick Tocknell, for HealthLeaders Media , August 1, 2011

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.

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