FDA Issues Final Mobile App Guidance
On September 23, the FDA announced much-anticipated final guidance on mobile medical applications, including apps that turn smartphones into medical devices. This guidance is very similar to the guidance previously released in July 2011.
While the lack of final guidance had not been an obstacle to some app developers, others had proceeded with caution to minimize regulatory risk. Some clues about FDA enforcement of mobile apps came in May, when the agency issued a letter to Biosense Technologies for its uChek urine analyzer app (see background here).Now that FDA has issued final guidance, the industry may continue to innovate with a better sense of what the FDA is most concerned with regarding mobile medical apps.
In keeping with its mission to protect public health, FDA confirmed it will regulate any apps that transform mobile platforms into regulated medical devices or apps used as accessories to regulated medical devices.However, FDA clarified they will "use discretion" with apps that don't pose a direct risk to public health, such as consumer health and wellness trackers.
In the press release, Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, stated, "Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly. The FDA's tailored policy protects patients while encouraging innovation."
Tailored Approach Provides Clarity, Leeway
Pharmaceutical companies wishing to create mobile apps for patients and healthcare professionals should understand how this guidance affects apps that are in-market or in the planning stages.
What Will Be Regulated?
The FDA will "apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended."
These may include heart monitors, blood pressure gauges, or blood glucose monitors. FDA has approved about 100 mobile medical apps already, a list of which has been published on the agency's website. Examples include:
FDA provided a helpful sample list of the types of apps on which it intends to focus on page 26 of the official guidance document.
In addition to stating what will be regulated, the FDA clarified that mobile medical apps will not require reevaluation for minor, iterative product changes. This should cover, for example, the frequent changes required as new versions of Apple's iOS, Google's Android and other mobile platforms are updated.
What May Be Exempt?
The FDA will exercise "enforcement discretion" for applications that may meet the regulatory definition of a "device" but do not pose risk to consumers. Common health and fitness apps that are designed to help people stay healthy do not pose much risk if they malfunction and thus are less likely to be federally regulated. According to the guidance, these include apps that:
- Help users self-manage their disease/condition without providing specific treatment suggestions
- Provide patients with simple tools to organize and track health information
- Provide easy access to information related to 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 record (PHR) or electronic health record (EHR) systems
For applications such as those listed above, the FDA will not require submission for premarket reviews. In addition to this list, FDA provided a list of specific examples of mobile apps for which they intend to exercise enforcement discretion.
While this final guidance closely reflects the draft published in 2011, pharmaceutical marketers should review any in-market apps or planned apps against it to determine if the app:
- May fall outside the medical device definition and therefore would not be regulated.
- May be considered a medical device or accessory to a medical device.
- If yes, if a possible malfunction could pose harm to patients, FDA would seek to regulate it.
- If yes, but the app carries minimal risk to consumers (i.e., skill-a-day or medication organization/tracking tools), it may be the type of app FDA is less likely to regulate.
Pharmaceutical regulatory and compliance professionals appreciate having clear direction from the FDA. We expect this guidance to help open up stalled or sidelined discussions surrounding mobile health apps. Overall, it provides clarity and reduces confusion, enabling pharmaceutical companies to bring even more valuable tools and services to their customers.