The Journal of mHealth Vol 2 Issue 4 (August) | Page 33

Walking a Fine Regulatory Line glass app to determine its suitability for that purpose. That means the app must work for that specific function. Customers are likely to rely on the claim. 3. Manufacturer intent versus customer use Key to understanding the concept of intended use is appreciating that it is the manufacturer’s intent, and not the customer’s actual use of the product, that matters. The burden of regulatory compliance falls on the manufacturer, so it is only fair to impose the FDA requirements when that intent crosses the regulatory line. Manufacturers cannot be held responsible for all of the uses to which a customer might put a product. Under FDA’s rules, an orthopedic surgeon can go to a hardware store to buy a saw for a surgical procedure. FDA would have no jurisdiction over that act. Instead, the doctor’s conduct is a state regulatory issue regarding physician licensing, and a medical malpractice issue under state tort law. 4. Promotional guardrails for staying out of regulatory waters To sell a general use product that includes a medical use without complying with FDA requirements, a tech company needs to make sure that all the evidence points to a general purpose use. Admittedly, that’s a bit easier said than done. I will offer three guardrails tech manufacturers ought to observe in marketing their general purpose products. a. Always include context Tech manufacturers should remember to always present their products with an emphasis on their general purpose functions. General purpose, generally speaking, can be communicated two different ways. •  First, the marketer can stay at a very high level in its description of the intended uses: “this cell phone is for communication purposes.” If your claims end right there, you have no FDA issue. •  Second, the marketer can illustrate the general range of uses. “This cell phone is for communication purposes and can be used by people for personal communications, workplace productivity, managing investments and healthrelated purposes.” While not as neat and clean as the first example, as explained more below, this too should work. 5. Collaborating with medical device partners If the health functionality is presented in a broader context as simply one part of an illustration, FDA typically will not treat that as a medical device type claim. Indeed, in the marketing arena, it’s almost impossible to stay truly general and still adequately convey what the product does. Often, for example, advertisements and packaging will include pictures of users. The picture of the user will convey some information, for example a business person would convey office productivity where a nurse would convey a medical purpose. The manufacturer needs to make sure that it is always conveying the fact that this is a general purpose article with a wide range of applications, one of which may be use in a medical setting. Never skip the general use. More and more, tech companies are collaborating, each focusing on their core strength and collaborating with others for work outside their domain. The temptation is for tech companies that make general purpose IT equipment to collaborate with medical device manufacturers, to communicate that the general purpose articles can support medical device use. That’s fine, but do not let that cause you, as the tech manufacturer, to get sucked into the medical device world. b. Avoid specific medical feature claims Remember the policy behind regulating medical specific claims: customers are likely to rely on specific claims when determining whether an article is suitable for their own purposes. The more a tech manufacturer touts specific features of their general purpose article as somehow specially or uniquely helpful to a medical purpose, they are creating an impression in the customer that this product has been in fact designed and tested for the medical purpose. For example, a cell phone manufacturer should not promote some specific design feature whose only purpose is to make the cell phone compatible with an EKG accessory. That would take the cell phone out of the realm of a purely general use article, and make it an accessory to the EKG device. Customers would be entitled to rely on its functionality with an EKG accessory. c. Avoid medical benefit claims In addition to avoiding medical feature claims, avoid making medical benefit claims. Don’t say, for example, that patients who use your cell phone with an electronic stethoscope app can better manage their arrhythmia. If you start claiming medical type benefits to using your general purpose product, you are very likely crossed the line into regulated medical device territory. If you are a cell phone manufacturer, for example, a company that makes a medical device app that can be used to control a blood pressure cuff, for example, can promote the use of its app with your cell phone, but that doesn’t mean that you can do likewise. The app developer’s promotion does not cause the cell phone to be regulated. But if you as the cell phone manufacturer decide to go on a campaign to promote the use of your cell phone with that app, you are running the risk of making that cell phone a regulated accessory to the app. 6. Guardrails on training and support After the sale, it is possible to in