Risky Business: FDA Mobile Medical Apps Final Guidance Focuses on Risk to Patient Safety
Health Law Update 10/23/13 Jennifer J. Hennessy
The FDA has issued final guidance on mobile medical applications (“apps”), which are mobile apps that meet the definition of a device and are intended to be used (i) as an accessory to a regulated medical device or (ii) to transform a mobile platform into a regulated medical device. The final guidance states that the FDA will apply its regulatory authority oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to the patient’s safety if the mobile app were to not function as intended. Accordingly, while some mobile apps may technically meet the definition of a “device,” the FDA will exercise enforcement discretion if those apps pose a lower risk to the public.
The final guidance provides examples of the type of mobile apps that the FDA does not consider to be devices, mobile apps that are devices but for which the FDA will exercise enforcement discretion because it views the devices as low risk, and lastly, mobile apps on which the FDA intends to focus its regulatory oversight. We address each of these below in turn.
Step 1: When is a Mobile App a Medical Device?
A mobile app will be considered a device if it is intended to perform a medical device function, that is, if its intended use is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man. The FDA states that the function of the mobile app, not the platform on which it runs, is the focus. Further, the FDA provides multiple examples of the types of products it does not consider to be devices, such as mobile apps that:
- Are intended to provide electronic copies of reference materials (e.g., medical dictionaries);
- Are intended for general patient education and to facilitate patient access to commonly used reference information (e.g. provide portal for provider to distribute educational information to patients);
- Automate general office operations in a health care setting (e.g., determine billing codes); and
- Are generic aids or general purpose products (e.g., magnifying glasses).
Step 2: Will the FDA Exercise Enforcement Discretion Over the Device?
The final guidance states that the FDA plans to exercise enforcement discretion (i.e., not focus its regulatory oversight) over mobile medical apps that fulfill one of the following six purposes:
- Help patients self-manage their disease or conditions 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 patients’ health conditions or treatments;
- Help patients document, show, or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- patients or providers to interact with Personal Health Record or Electronic Health Record systems.
The final guidance provides additional detail and examples of each of these categories.
In contrast, the FDA states it will focus its regulatory oversight on mobile medical apps that:
- Transform a mobile platform (such as a smart phone) into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices (e.g., mobile apps that use an attachment to the mobile platform to measure blood glucose levels);
- Connect to an existing device type for purposes of controlling its operation, function, or energy source (e.g., mobile apps that control the inflation or deflation of a blood-pressure cuff);
- Display, transfer, store, or convert patient-specific medical device data from a connected device (e.g., mobile apps that connect to a nursing central station and display medical device data to a physician’s mobile platform for review); or
- Perform patient-specific analysis and provide patient-specific diagnosis, or treatment recommendations (e.g., radiation therapy treatment planning software).
Step 3: The FDA Plans to Focus its Regulatory Authority on My Mobile App. Now What?
If the FDA considers the device to be subject to FDA regulatory oversight, the mobile app manufacturer must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification (Class I, II, or III), the manufacturer must follow the requirements associated with that classification.
For more information, please contact Jennifer Hennessy at (608) 283-2405 / firstname.lastname@example.org, or your Quarles & Brady attorney.