The Journal of mHealth Vol 2 Issue 4 (August) | Page 32

Walking a Fine Regulatory Line Walking a Fine Regulatory Line: Selling General Purpose IT Equipment for Specific mHealth Applications By Bradley Merrill Thompson Tech companies have noticed the mhealth market. They have products like smart phones, routers, and other communications equipment that have uses in many different industries, including healthcare. They want to enter the healthcare market but they wish to avoid regulation by the U.S. Food & Drug Administration (“FDA”). Unfortunately, many of those companies struggle to understand the definition of a regulated “medical device” and the degree to which they can promote their products for medical use without crossing the line into FDA territory. Many, for example, want to know whether, in their promotional materials, they can discuss medical uses without having to comply with U.S. medical device requirements. The answer is yes, but they need to walk a fine line. 1. It all starts with intended use The foundation of medical device law is the concept of intended use. Paraphrasing the U.S. statute a bit, the line that defines a regulated medical device is drawn based on how the manufacturer intends its customer to use the product. Generally speaking, if the manufacturer intends the customer to use the product in the diagnosis or treatment of disease or other conditions, FDA will regulate the product as a medical device. This definition tends to frustrate people who like clear-cut rules. Compared to a rule, for example, that the Federal Communications Commission regulates all nonfederal use of the radio frequency (RF) portion of the electromagnetic spectrum, the medical device definition is certainly less precise. But the principles behind it are relatively clear. 30 August 2015 Intent is established through evidence. Think of any murder trial you’ve seen on TV. The government establishes the intent of the alleged murderer through evidence-- evidence that typically includes statements by the defendant that reveal his intent, or actions from which the judge or jury can infer intent. Establishing intent for the use of medical -related products is likewise evidencebased. The government first and foremost looks at the promotional claims the manufacturer makes, and the uses of the product those claims suggest. 2. Understanding general versus specific intended uses Here is where things get interesting. Interpreting words has never been a simple exercise. The fact is words have lots of different meanings, and when you string them together in various ways they can have very subtle differences in meaning. Let’s say I have a mobile app that uses the camera and the screen on a smart phone to view stuff at a 10 X magnification. In promoting the sale of that app, there are hundreds of ways I might describe it but let’s look at two. First, I could call it a “magnifying glass app.” Its function is to make stuff look bigger. Second, I could call it a “dermatology magnifying glass that is useful in looking at moles to assess them for possible melanoma.” Under U.S. law, clearly I can sell an app that I promote as a magnifying glass without any need to comply with FDA requirements. That app quite simply is not a medical device. At this point, a philosophy major may be thinking that, using syllogistic logic, if an app that can be used to magnify anything is lawful without FDA compliance, then an app that could be used in any manner that is consistent with that intended use would likewise not require FDA compliance. If the philosophy major also majored in math, he may think in terms of sets, and conclude that any product intended to fall within the set defined by the general purpose magnifying glass claim should likewise be lawful. The problem is: the philosopher would be wrong. FDA does not regulate the first intended use but does regulate the second, even though logically it fits within the first. FDA is not run by philosophers, but rather by clinicians. The more specific intended use is regulated even though the general use is not because there are risks associated with the specific claim that are not present in the general claim. FDA explains its thinking in a guidance document entitled “General/Specific Intended Use” issued in November 1998. While that guidance does a very