DSW in action

In a single response to a request from one company in 2009, and then subsequently in 2011 through a draft guidance document, the Food & Drug Administration (FDA) is sweeping aside decades of agency practice on how it determines what is a “medical device” and what is a “drug.” The distinction is a critical one for health product companies, as the drug approval process in generally far lengthier and more expensive than the device process. Equally or more important, however, is that FDA’s decision-making approach evaded public and legislative accountability.