By Keith Barritt, Fish & Richardson P.C.
There seems to be no escaping the ubiquitous onslaught of wearable sensors designed to monitor and measure all kinds of physical parameters. Often, these devices have Bluetooth connections to your smartphone to allow for greater processing and storage of data. Determining when these products are subject, as medical devices, to regulation by the U.S. Food and Drug Administration (FDA) is a very hot topic, both at the agency and in the industry.
Start‑up companies, in particular, are perhaps most at risk, as they may not even realize their apps might be subject to FDA regulation. Nonetheless, there are steps companies can take to minimize the chance that they will be the unlucky recipient of an FDA letter warning of dire consequences for marketing an unapproved — hence, illegal — medical device.
Is My App A Medical Device?
The best place to start any discussion about FDA “medical device” regulation is a refresher on the FDA definition of a medical device. To paraphrase, the agency states that a medical device is an instrument, apparatus, implement, machine, contrivance, or other similar or related article, including a component part or accessory, that is intended:
- For use in the diagnosis of disease or other conditions;
- For use in the cure, mitigation, treatment, or prevention of disease; or
- To affect the structure or any function of the body.
Some apps may purport usage of a smartphone to affect the structure or function of the body by claiming, for example, phototherapy to treat acne or other diseases/conditions. However, the vast majority of issues that arise in app classification involve trying to determine if an app is intended for use in the diagnosis of diseases/conditions, or in the cure, mitigation, treatment, or prevention of disease.
It has long been recognized that software, whether as an accessory to an existing device or not, can qualify as a regulated medical device. The FDA’s software policy has gone through several changes over the years, and recent guidance documents have helped to focus the agency’s regulatory gaze. Accordingly, understanding these guidance documents can help developers steer clear from the FDA’s watchful eye.
FDA Mobile Medical App Guidance
In February 2015, the FDA released an amended final guidance on the regulation of mobile medical apps. That guidance defines a “mobile application” as software that can be run on a mobile platform, or a web-based software application that is tailored to a mobile platform but executed on a server. The FDA defines a “mobile platform” as being “handheld in nature,” such as iPhones, iPads, or other personal digital assistants, though it probably is prudent to interpret the FDA guidance as applying to all software in general, regardless of the type of platform.
A mobile app is a regulated mobile medical app if it fits within the definition of medical device (i.e., it is intended to diagnose disease or other conditions, such as pregnancy; cure, mitigate, treat, or prevent disease; or affect the structure or function of the body). Intended uses may be established through labeling claims, advertising, website promotions, and even oral statements by the manufacturer or its representatives. The formal labeling of a product is not necessarily the end of the story when determining intended use — how the product actually is marketed is the key.
Accordingly, FDA jurisdiction does not necessarily extend to all self-stylized mobile “health” or “telemedicine” apps. Rather, only mobile apps that are “medical devices” as defined by law are covered. The FDA lists three broad categories of intended uses (and gives dozens of specific examples) that would classify an app as a medical device, thus making it subject to regulation:
- The app controls another connected medical device. The FDA considers such software to be an “accessory” to the connected device and subject to the same regulatory treatment as the connected device. An example is software that controls the delivery of insulin by transmitting control signals to a pump.
- The app transforms the mobile platform into a regulated device. The FDA considers the software and associated platform to be regulated the same as the device into which it has been transformed. Such products may include attachments to an existing device. An example is an app that allows for the attachment of a transducer to convert a smartphone into a stethoscope.
- The app performs patient-specific analysis and provides patient-specific diagnosis or treatment recommendations. An example of this type of device is an app that uses patient-specific information to calculate dosage or create a dosage plan for radiation therapy. However, the FDA has not yet issued guidance for software that provides more advanced clinical decision support.
What Isn’t Regulated?
The mobile medical app guidance lists several categories of mobile apps for which the FDA plans to exercise enforcement discretion but not actively regulate. These include apps that:
- Help users self-manage their disease or condition without providing specific treatment or treatment suggestions
- Provide patients with simple tools to organize and track their health information
- Provide easy access to information related to a patient’s health conditions or treatments
- Help patients document, show, or communicate potential medical conditions to healthcare providers
- Automate simple tasks for healthcare providers
- Enable patients or providers to interact with personal health records or electronic health record systems
What About Medical Device Data Systems (MDDS)?
The FDA’s mobile medical app guidance initially categorized “medical device data systems” as a type of app subject to regulation. MDDS devices display, store, or transmit patient-specific data from a medical device in its original format, or convert it according to preset specifications. MDDS devices may not be used to analyze or manipulate the data, generate signals that control another medical device, or actively monitor a patient.
In recognition that the ability to transmit data is fundamental to the digital health revolution, the FDA announced in February 2015 that MDDS devices — including the similar medical image storage devices and medical image communications devices — would be deregulated completely. This move has greatly simplified innovators’ ability to develop mobile medical apps and other devices that fit within the MDDS definition.
The FDA moved quickly on this issue, following up on a draft guidance it had issued only eight months earlier. This important step should encourage the industry to develop more MDDS devices, which the FDA described as the “foundation” for the inter-communication necessary to ensure the “better, more efficient patient care and improved health outcomes” offered by digital health technologies.
FDA Draft “Wellness” Guidance
In another sign of deregulatory action to come, the FDA released in January 2015 a draft guidance document entitled “General Wellness: Policy for Low Risk Devices.” The draft guidance reflects the FDA’s continuing efforts to clarify the scope of its regulations and to further promote development of digital health products.
There is no guarantee the draft guidance ever will be finalized. However, it reflects the agency’s current thinking and offers a potential new path from the FDA’s usual approach of explaining why certain products do not fall within the formal definition of “medical device.” Instead, the draft guidance states that the FDA does not even intend to examine whether “low-risk general wellness” products are devices or whether they comply with the Food, Drug, and Cosmetic Act. The agency’s approach seems to borrow from its light-touch regulation of dietary supplements, for which certain nondisease‑related “structure/function” claims may be made that describe the role a supplement plays in affecting or maintaining the “normal” structure or function of the body.
The FDA draft guidance sets forth two categories of products that qualify as low‑risk “general wellness” products, based on the intended use of the products. The first category includes products intended to help maintain or encourage a general state of health or healthy activity. The key to fitting in this category is avoiding reference to a specific disease or condition, a rather traditional approach to avoiding FDA regulation.
Per the FDA, claims that fit within this category include weight management, relaxation or stress management, sleep management, and products for mental acuity, self-esteem/appearance, physical fitness, and sexual function. However, claims that include reference to specific diseases such as obesity, anorexia, autism, or erectile dysfunction do not fall within this category.
The second category of “general wellness” products includes those intended to promote, track, and/or encourage choices that may help to reduce the risk of, or the ability to live well with, certain chronic diseases or conditions. The focus on empowering individuals with information to make “healthy lifestyle choices” as a basis for regulatory forbearance is rather unconventional. Claims may refer to specific diseases or conditions only when it is well understood (e.g., described in peer-reviewed scientific publications) that healthy choices may reduce the risk or impact of a chronic disease or condition.
FDA-provided examples of claims that fit within this category include products that promote physical activity to help reduce the risk of high blood pressure, track caloric intake to maintain a healthy weight and balanced diet to live well with high blood pressure and type 2 diabetes, or track sleep patterns to help reduce the risk of developing type 2 diabetes.
It is not immediately clear why only products that assist with “chronic” diseases or conditions should qualify under this category. For example, a mobile app that reminds users to wash their hands to help prevent a temporary cold or flu seems to promote the type of “healthy lifestyle choice” that the FDA intends to encourage.
Other examples given by the FDA of low-risk general wellness products are specific to mobile apps such as those that:
- Play music to “soothe and relax” and to “manage stress”
- Monitor and record daily energy expenditure and cardiovascular workout activities to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health”
- Monitor and record food consumption to “manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity”
The most conservative approach to avoiding FDA regulation is to steer clear of any claims that an app is intended to diagnose a specific disease or condition, or to treat, cure, prevent, or mitigate a disease. Low-risk apps for promoting “general health or wellness” are unlikely to be regulated, though it is always best to consult with FDA counsel before marketing your product to ensure that the regulatory landscape has not changed again in this fast-moving area.
Developers of software with a medical purpose should welcome FDA efforts to bring some clarity to what is inherently a very murky area. While no guidance document, or even final regulation, is free from gray areas, the FDA has at least advanced the ball on helping developers determine whether their software would be considered a regulated “medical device.” If software falls within the FDA’s jurisdiction, developers would be wise to fully comply with the applicable regulations.
About The Author
Keith A. Barritt is a principal in the Washington, D.C., office of Fish & Richardson. His practice is primarily focused on all aspects of trademark law as well as all aspects of medical device regulation by the FDA, including obtaining marketing authorization for medical devices, use of new devices for investigational purposes, and import and export issues. Barritt has prepared and filed dozens of 510(k) pre-market notifications, ranging from innovative lasers to software-based surgical devices. He advises clients on issues involving quality system regulations, device labeling, medical device reporting obligations, recalls, device listing, establishment registration, and import/export regulations. To contact him, visit www.fr.com/keith-a-barritt.