US FDA's de novo proposal will not result in significant time saving, says medtech association
This article was originally published in SRA
Executive Summary
US medtech industry association AdvaMed does not think that the Food and Drug Administration's proposal to streamline its de novo process (that is used for innovative, low- to moderate-risk devices that cannot be cleared by the pre-market notification, or 510(k), process) will result in any significant time saving for medtech companies as is being claimed by the agency1,2.