Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in the Bloomberg Law Health IT Law & Industry Report, titled “Business Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things.”
Following is an excerpt (see below to download the full report in PDF format):
Generally speaking, FDA regulates many aspects of the HCIoT, but not all. Discerning which portions FDA regulates and which they do not generally revolves around the intended use of the product when sold by the manufacturer.
In a previous article (see previous article), we examined the present state of FDA regulation of the Health Care Internet of Things (HCIoT). Building on that, in a second article (see previous article) we analyze various marketing strategies that could reduce the scope of FDA regulation. There are, however, limits on just how much careful marketing can limit the scope of FDA’s reach, so this third article examines business strategies that will reduce the burden of FDA regulation on those portions that the agency oversees.
Resources
Part 1: Strategies for Technology Companies Entering the Health Care Internet of Things