FDA 'Open' to 510(k) Proposals

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

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.
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