Memorandum

FDA releases draft guidance on mobile medical applications – July 21, 2011

Executive Highlights

  • The FDA released a draft guidance document narrowly defining what types of mobile applications will be reviewed and regulated by the Agency.
  • These so-called “mobile medical applications” will be subject to the FDA’s existing device requirements.

Earlier this week, the FDA released a draft guidance document to clarify the types of mobile apps that the Agency intends to apply its regulatory requirements (what it calls “mobile medical applications”). The 30-page document focuses on defining what constitutes a mobile medical application: primarily, applications that diagnose, treat, or mitigate diseases or connect to other medical devices will be regulated, while simple wellness apps (e.g., exercise suggestions, calorie counters) will not be subject to FDA oversight. Existing FDA device requirements will apply to apps that do meet the criteria for mobile medical applications, although it’s often unclear in the document that classes of device regulation will apply to specific types of apps. In our view, this gray area will likely be a point of contention between companies and the FDA going forward. The release of the draft guidance signals the FDA is taking mobile health quite seriously, and as we understand it, the guidelines were released quite quickly by the Agency’s standards.

In our view, the draft guidance document is a good first step for the FDA and should result in improved patient safety in the long run. However, we also wonder whether general requirements like these are appropriate for a space as dynamic and innovative as mobile health – as a reminder, the 1989 “Draft Software Policy” was withdrawn because innovation was too rapid. Additionally, we would assume these requirements will result in a large increase in the number of companies seeking to speak with the FDA, and considering the Agency’s limited resources, will almost certainly lengthen the approval process or pull resources from other divisions. More importantly, we forecast that these new requirements will likely slow innovation in the field, or worse, reduce the number of players in the mobile app development space. Some of this is likely healthy and we hope that the most robust survive. The draft guidance document can be found at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/... UCM263366.pdf. We do note that the FDA itself was on Twitter on the day of the release asking for feedback – that was really something! Follow @FDADeviceInfo on Twitter for more on that front …

  • The history of official, published FDA regulation of computer and software products is relatively short. The FDA drafted a document called the “FDA Policy for the Regulation of Computer Products” (also known as the “Draft Software Policy”) in 1989, but the pace of technological innovation was so rapid that the policy was withdrawn. On February 15, 2011, the FDA issued a new regulation that down-classified (from high-risk, class III to low-risk, class I) certain computer- or software-based devices intended to be used for the electronic transfer, storage, or display of medical device data.
  • The FDA is taking a “narrowly-tailored approach” and will only apply its regulatory requirements to a subset of mobile apps defined as “mobile medical applications.” Mobile apps must meet two criteria to be deemed “mobile medical applications.” First, they must satisfy the definition of a “device” as specified in section 201(h) of the Federal Food, Drug, and Cosmetic Act (i.e., the intended use is the cure, mitigation, treatment, or prevention of disease, or where the intended use will affect the structure or any function of the body). Second, for an application to be defined as a “mobile medical application,” it must either be used as 1) an accessory to a regulated medical device or 2) it must transform a mobile platform (e.g., smart phone, tablet computer) into a regulated medical device. Applications that fall outside these criteria will not be subject to the FDA’s regulatory authority.
  • Apps that control medical devices (e.g., insulin pumps) or transform mobile platforms into medical devices (e.g., AgaMatrix/Sanofi’s iBG Star) will be subject to existing FDA device requirements (class I, II, or III). We were not surprised to see that the FDA will regulate mobile apps that connect to a medical device for the purposes of controlling it. In these cases, the application will be deemed an accessory to the connected device and required to comply with the controls applicable to that connected device. This policy will certainly have implications for companies with planned mobile phone connectivity like Cellnovo and Debiotech’s insulin pumps. Unsurprisingly, devices like AgaMatrix/Sanofi’s iBG Star (a glucose meter designed to work with the iPhone) will also be subject to FDA oversight. These types of mobile apps, which transform the mobile platform into a medical device by using attachments, display screens, or sensors, must comply with the device classification associated with the transformed platform.
  • Mobile applications that connect to medical devices will also strong>be required to comply with FDA regulations. Applications that connect to a medical device in order to display, store, analyze, or transmit patient-specific data will need to comply with class I device requirements. Devices like Dexcom’s future-generation CGM (see January 18, 2011 Closer Look for more about Dexcom’s future system from JP Morgan Day #4), which will reportedly display sensor values on a mobile phone, will fall under these requirements. Finally, the FDA will regulate mobile applications that allow users to input information and – using software – output a patient-specific result, diagnosis, or treatment recommendation (e.g., the WellDoc DiabetesManager). Such applications will be subject to the same regulatory requirements as the connected device. We’re somewhat unclear on what this language will entail, as the connected device may not always be obvious. For instance, we wonder about mobile applications that allow users to input blood glucose data and then perform calculations that result in an index or score. What would be the connected device in this case? It seems unfair to require such apps to comply with blood glucose monitoring device requirements, as they pose far less risk. Hopefully, future guidance and policy will provide greater clarity on these issues.
  • The FDA is concerned about device failures as a result of software design errors and will require that manufacturers of mobile medical applications follow the Quality System Regulation (QSR). According to the draft guidance, the FDA has found that the majority of software-related device failures are due to design errors; in one study, the most common problem was failure to validate software prior to routine maintenance. With this in mind, manufacturers will be required to comply with the QSR: “a framework for all manufacturers to develop and follow to help ensure that their products consistently meet applicable requirements and specifications.” Going forward, mobile medical app manufacturers will be required, as part of the QSR (21 CFR 820.30), to appropriately verify and validate their mobile medical apps along with the mobile platform to ensure safety and effectiveness.
  • General health and wellness apps (e.g., dietary tracking logs, exercise suggestions) as well as applications that function as electronic health records will not be considered “mobile medical applications” by the FDA. The reason, according to the FDA, is that such applications are not intended for curing, treating, or diagnosing a specific disease or health condition. We were glad to see no proposed regulation of these types of mobile applications by the FDA. General health and wellness apps are increasingly being developed and used by thousands of people and FDA requirements would no doubt hamper development and adoption. In our opinion, these sorts of applications, which may help users exercise, eat right, diet, and improve their lifestyle habits, may play a very helpful role in stemming the type 2 diabetes epidemic.
  • In what may prove relevant to the artificial pancreas, future documents will address mobile medical applications that interface with more than one medical device. According to the draft guidance document, applications that interface with multiple medical devices may result in either increased or decreased risk depending on the circumstances. As a result, the FDA is encouraging manufacturers of these types of mobile medical applications to contact the Agency to determine the classification of their mobile app. Additionally, the FDA will seek public comment on how it can provide greater clarity for these types of mobile medical apps.
  • Separate draft guidance documents will address wireless safety considerations, classification and submission requirements related to clinical decision support software, and the application of quality systems to software. Regardless, the Agency encourages manufacturers of “mobile apps with novel technologies” to speak with the FDA for clear direction on the process of clinical testing and development.

--by Adam Brown and Kelly Close