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 BNA IT Law & Industry report, titled “Strategies for Technology Companies Entering the Health Care Internet of Things.”
Following is an excerpt (see below to download the full report in PDF format):
Technology developers looking at the opportunities presented by the HCIoT for managing chronic disease often ask themselves whether a given piece of hardware or software to be used in that ecosystem would be subject to FDA regulation. The question is a natural one, as FDA regulation carries with it certain costs and timelines associated with compliance that have a direct impact on the attractiveness of the market. Certainly not all regulated medical devices must receive FDA clearance before being marketed, but some do, and obtaining that clearance or approval in some cases requires expensive data as well as the patience to go through the process.
While the answer to the question of whether a given product is regulated isn't always clear (because the facts get complicated very quickly and FDA has not issued guidance for many of the more complex areas), at a high level, FDA's jurisdiction is actually fairly simple to explain. Medical devices include just about anything that is “intended for use” in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man.
The first three words of that definition—intended for use—turn out to be extremely important. The scope of FDA medical device regulation is based on the “intended use” of the product being sold. The phrase “intended use” has a specific meaning, and it is often different from the actual use to which a product is put. The intended use is the use the seller intends the buyer make of the product. In other words, to determine whether a product is FDA regulated, the task is to look inside the seller's mind at exactly for what the seller intends its product to be used.
This makes sense. It would be completely unworkable, and frankly unfair, if we held sellers responsible for unforeseen uses that a particular customer makes of a given article. Instead, to make the system objective and predictable, we base the decision of FDA jurisdiction on the seller's intent.
