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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 two initiatives that he says will have the biggest impact...

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