MDMA’s Advice To FDA On 510(k) Reform: Tone It Down
This article was originally published in The Gray Sheet
Executive Summary
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.