In his insightful 10x Medical Device Conference talk, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner… protect[ing] the public health by ensuring… reasonable assurance of the safety and effectiveness of devices intended for human use….

But Gulfo says FDA is no longer content approving safe and effective drugs and devices with pre-approval requirements skyrocketing. We need to use our voices to get FDA back to focusing on safety and effectiveness and letting the market decide the clinical utility and winning products.