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.
The FDA's proposal, which aims to trim off up to 90 days from the de novo programme, was outlined in...