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MDMA’s Advice To FDA On 510(k) Reform: Tone It Down

Rather than take on so much at once, FDA should focus its 510(k) reform efforts on a few initiatives that will have the most bang for the agency’s buck, Medical Device Manufacturers Association’s Mark Leahey says. MDMA’s suggestions? Implement the new “network of experts” program and risk-benefit guidance.

If industry trade group leader Mark Leahey could give FDA one piece of advice as the agency begins another year of 510(k) reform efforts, it would be: Narrow the focus.

According to Leahey, president and CEO of the Medical Device Manufacturers Association, FDA should focus its efforts in 2012 on...

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