Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA’s view, diagnoses and treats disease.
The App knows all
Pierre designed an app where you can upload a photograph of a suspicious area on your skin and get feedback as to your potential risk that the lesion is cancerous (or benign).
Pierre wants to know whether his app is regulated by FDA.
Pierre’s plan is to market the app in two stages. In the first stage, the app transmits the photograph to physicians who will render a diagnosis and send it back through your mobile phone.
In the second stage of development, once Pierre gets Series A funding, the app itself will be intelligent; an algorithm will assess and pronounce your risk level.
Live long and prosper
Pierre’s stage 1 is pure telemedicine. The app collects medical information, whether online or through an (or for that matter, a virtual reality headset or wearable) and that information goes to a medical doctor, who then makes a diagnosis.
Stage 2 is more automatic. The algorithm decides and tells you whether you will live long and prosper, or should see a medical doctor right away.
This is where health tech is going. We are moving from medical services to medical products. What can be done quicker, cheaper, faster by a machine that learns – a cognitive machine – will be offloaded from human medical doctors.
And here, FDA has spoken.
Mobile medical app nutshell
Let’s start with the definition of medical device in federal food, drug and cosmetics law. A device is:
…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent…. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man… or … intended to affect the structure or any function of the body of man or other animals…
FDA handily divides mobile apps into three categories:
- mobile apps that likely are not medical devices
- mobile apps that likely are medical devices (and hence subject to medical device regulation)
- mobile apps where FDA retains enforcement discretion to put them into one of the first two categories
In its mobile medical app Guidance, FDA explains that in deciding on which apps it will focus its Doctor T.J. Eckleburg eyes, it is conducting a risk-based analysis:
Thus, software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud,” or on a handheld computer may be subject to device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The level of regulatory control necessary to assure safety and effectiveness varies based upon the risk the device presents to public health.
This goes back to FDA’s “intended use” doctrine. If the app is intended for use to diagnose and treat disease, then it is a medical device.
Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care….
Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness.
Let’s not kid ourselves; Pierre’s app is designed to analyze skin lesions for cancer. This is not a general wellness proposition; it’s disease care.
So when the app itself makes the determination, we’re in mobile medical app / medical device territory.
The camera issue
The camera is part of the smartphone. But when it is used to upload an image and that image becomes the basis of a diagnosis, FDA becomes involved.
Among the examples of mobile apps that FDA gives in its Guidance are these:
- Mobile medical apps that are extensions of regulated medical device for purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient-specific medical device data.
- Mobile medical apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions.
In the first category, FDA includes “apps that allow the user to view medical images on a mobile platform and perform an analysis or process for diagnosis.”
In the second category, FDA examples include:
- Apps that use a mobile platform’s built in features such as light, vibrations, camera, or other similar sources to perform medical functions;
- Apps that use pictures and sound to diagnose conditions by comparing to previously determined diagnoses of images, symptoms, sounds, or other physiological measurements.
So: is Pierre’s app a regulated medical device?
Yes, if the app uses the camera feature in mobile devices to capture photographs that would be considered “medical” files when used for purposes of diagnosis.
Among other things, this means that Pierre must follow FDA’s Quality System regulations (which include good manufacturing practices), and promptly address design errors.
Pierre knows this is costly, so he’s going to put the product on the market in Stage 1 and rake in as much profit as possible, and then secure a new round of funding for the algorithm piece.
Device classification matters
FDA can classify a device as Class 1, 2 or 3.
Class 3 is the strictest, and means that the device requires premarket approval, which means clinical trials, extensive testing, and big budgets.
Class 2 typically requires substantial equivalence to a medical device that has already been cleared for sale in interstate commerce. Assessing substantial equivalence is one of the tasks of an FDA attorney, who checks predicate devices to see if there’s an argument for substantial equivalence.
Sometimes there is no predicate device, and a de novo submission to FDA is required, as otherwise the medical device may get automatically pegged as Class 3.
So, from a strategic point of view, it’s best if you limit claims so that you don’t have a “medical device” at all; but if you must make diagnosis and treatment claims, for the sake of your marketing strategy, then have legal counsel advice on what claims put you into the higher, more burdensome and expensive, regulatory classification.
As the Upanishads put it: “He who thinks he knows, does not know. He who knows he does not know, knows.”
In other words, it isn’t “what you don’t know you don’t know.” It’s knowing that you don’t know that can be the difference between a business approach informed by legal strategy, versus one informed by hindsight.
Where the smartphone camera is used, one thing to consider is the exempt medical device category known as an MDDS (medical device data system). This is:
a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
(i) The electronic transfer of medical device data;
(ii) The electronic storage of medical device data;
(iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
(iv) the electronic display of medical device data.
It’s important to assess potential classification of your medical device at the outset, as these questions will be highly relevant to investors (and to potential company revenues).
FTC recently conducted enforcement action against the manufacturer of an app that claimed to detect melanoma risk:
The Federal Trade Commission has challenged marketers for deceptively claiming their mobile apps could detect symptoms of melanoma, even in its early stages.
The gist of FTC’s complaint is that the claim that the app itself could compare uploaded photographs to a database of lesions, and assess melanoma risk with any degree of significant accuracy, could not be adequately proven.
In short, the claim was false and misleading because it was not supported by competent and reliable scientific evidence.
Marketers of apps who step into the medical space should be prepared with a legal strategy that takes into account FDA and FTC risks.
If the app is not in the mobile medical space, but stays within telemedicine, there are also issues such as whether:
- the physicians are licensed in the patient’s state
- an initial face-to-face exam with the patient is necessary
- the procedure follows standard of care
- proper informed consent is given
- the relationship between the physicians and the app developer is properly structured in light of corporate practice of medicine and fee-splitting concerns
State law typically governs telemedicine concerns, while federal law rules the FDA and FTC aspects.
As we shift more and more from healthcare services and products, we’ll see increasing pressure on businesses to monitor FDA and FTC legal risk. A proactive strategy is wise.