Medical device Design Reviews are critical to the success of product development. So much so that the infamous Design Controls waterfall diagram shows a design review after every major design control ...

Staff units evaluating high-tech surgical robots and insulin-delivery systems were gutted by Trump layoffs even though industry fees, not taxpayers, financed the employee salaries. By Christina Jewett ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

Some scientists assigned double the number of new product applications for review Some deadlines for tobacco products will not be met and the start of new applications have been delayed, scientist ...

WASHINGTON (AP) — The Trump administration’s effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend, as recently hired employees who review the safety ...