It can come as a bit of a shock to people in the consumer electronics, IT and telecommunications industries that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services. My goal is to outline the factors that FDA considers when deciding whether to regulate such equipment.
Defining a medical device
The natural place to start is with the definition of a medical device. Since it is so central to the analysis, I’m going to quote the statute verbatim. Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:
“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.”
So at a high-level, we look for two things: (1) a device with (2) a medical intended use. The first prong of the test — that there must be an actual product — means FDA doesn’t regulate, for example, medical procedures. The thing in question must be a thing, and not information or something else intangible. Software can be a medical device if it’s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a “thing” for FDA to regulate.
Components vs. Accessories
In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.
That makes a big difference in terms of applicable regulatory requirements. Components are exempt from most FDA regulatory requirements, with the regulatory burdens being borne by the finished device manufacturer. Accessories, on the other hand, since they go right to the end user, must meet the FDA requirements before they leave the hands of the accessory manufacturer. These differences are summarized in Table A below:
TYPES OF DEVICES
Finished Stand alone parent device
A medical device in finished form, ready to use perhaps with accessories, intended for sale to the end user
An article intended for use in or with a finished medical device, intended for use by the end user
An article intended for use in or with a finished medical device, intended for use by a manufacturer
FDA Clearance required?
Yes, unless exempt
Yes, unless exempt
Yes, unless exempt
Yes, unless exempt
No, but quality must satisfy finished device manufacturer
The level of regulation imposed by FDA on accessories and components is determined by the parent device to which they relate. So if the accessory relates to a high risk device, say an implantable cardiac defibrillator, it will be subject to a high level of regulation even if the accessory is relatively benign in and of itself.
Having decided that the product meets the “thing” test, determining the intended use of the article can be much more difficult. As a preliminary matter, in the definition above you can see that the so-called medical uses are very broad, and include some conditions people may not ordinarily consider medical. For example, equipment used for exercise could become a medical device if the claims take on more of a therapeutic nature instead of simply suggesting general fitness. So if the piece of fitness equipment is specifically advocated for use in the treatment of obesity or rehabilitation of cardiac patients, it can become a medical device. Further, the definition is not limited to disease, but also relates to articles that affect the structure or function of the body (for example, pregnancy). Moreover, devices that merely monitor a body function, with no therapeutic effect, can fall into the device category if the intended use suggests a health-related purpose.
Determining “intended use”
Figuring out the actual intended use of the article depends entirely on the facts. I teach this topic at Columbia Law School, and I generally begin the session by taking out a popsicle stick. To employ a case study, I tell the students that I’m the CEO of a company that makes these sticks, and I want to know whether I have to comply with FDA regulations. At that point I encourage them to ask questions of me in my hypothetical role as CEO, and then ultimately to advise me.
If they have done their homework, they will start to ask me how I promote the stick. In my answers, I’m pretty coy at first, simply explaining that I sell sticks and what my customers do with them is their business. I explain that my labeling for the product merely identifies the product as a stick without going into its possible uses.
Hopefully my students have read enough to know that the regulations define “intended use” as: “the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. ?…” So what I say in my labeling is not the last word, but ultimately what matters is the totality of what I have done to promote the article and to some extent what I know about how my customers are using it.
Eventually my students start asking me about what trade shows I attend, what types of magazines I use to advertise the sticks, what my salesmen say to customers, and what I know about the actual usages of the sticks. And it turns out, in my hypothetical, I know that many of my customers are using them as pediatric tongue depressors, I promote them in advertisements in hospital journals, and at least some of my salesmen might encourage their use as tongue depressors. So eventually my students come to the view that my simple popsicle sticks might in fact qualify as medical devices and be subject to FDA regulation.
Advice for wireless health start-ups
Companies engaged in making mobile phones (or related articles or software apps) need to go through the same analysis to figure out if they are selling medical devices. They need to look first and foremost to the labeling and other promotional materials they use, but then also consider how they promote the products. In this regard, it’s important to remember that we’re looking for either an intended use directly as a medical device, or an intended use as an accessory to a medical device. It’s more likely a cell phone or related software might end up as a regulated accessory, than a stand alone medical device.
If it isa medical device, what next?
This analysis only answers the threshold question of whether an article is a medical device. If it turns out to be a regulated article, a second step is to figure out the degree of that regulation. A fair number of medical devices are exempt from FDA premarket clearance, and others are exempt from the obligation to employ good manufacturing practices. The risks associated with the intended use determine the level of regulatory requirements, including validation and other design rigor that FDA would require.
Not the end of the world
Merely being a medical device is by no means the end of the world, just the starting point for the analysis. Companies need to be mindful of these consequences as they develop their promotional programs for hardware and software in this mobile health space. FDA is almost certainly looking.