The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its ...

It waded into the enforcement area of medical device versus Medical Device Data Systems (“MDDS”) and Clinical Decision Support (“CDS”) Software. 1 In this case, FDA found that the product ...

Over the past two decades, with the rise of corporate entrants into healthcare—including the growth of integrated delivery networks (IDNs)—medical device manufacturers and their sales ...