Regulatory Alert

FDA Draft Guidance on Medical Apps Released
August 4, 2011 Analyst: Dale Cooke

EXECUTIVE SUMMARY
FDA is clearly articulating an intention to regulate certain mobile applications (apps) as medical devices or accessories. Clients should immediately review existing mobile apps and plans for future mobile apps to see whether they would be classified as medical devices or accessories under the draft guidance. If the apps would be classified as devices according to this draft guidance, clients should begin a dialogue with the relevant contacts at the FDA about what requirements they will have to fulfill to be compliant.

BACKGROUND
On July 21, 2011, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research issued a draft guidance entitled Mobile Medical Applications. This guidance is intended “to clarify the types of mobile apps to which the FDA intends to apply its authority.” (page 4) For 90 days following the official release of this guidance, FDA will be accepting comments about this document. FDA will review those comments and determine whether there is a need to revise this guidance. FDA frequently has major revisions to a guidance from its draft version to its final version; however, it is also true that FDA frequently does not revise a draft guidance or never issues a final version of a guidance. Consequently, it is prudent to begin acting on this draft guidance while recognizing that it is subject to revision.

RELEVANT FACTS
A guidance document has a specific purpose. A guidance document does NOT establish new requirements or regulations. Rather a guidance document is the FDA’s attempt to present its “current thinking on [a] topic.” (page 4) As such, even when a guidance document is not formally finalized in accordance with the process outlined in the Good Guidance Practices issued in 20001, the document still provides a window into the FDA’s views on a topic. In addition, because a guidance document does not constitute new regulation, there is no need for FDA to wait before acting on the views set out in a guidance document. Indeed, in many cases, readers of guidance documents see the documents as encapsulating views that have already been playing out in specific enforcement actions.2 The specific scope of this guidance document is intended to establish the “subset of mobile apps that it is calling mobile medical applications or ‘mobile medical apps.’” (page 4) The FDA defines the subset of mobile apps that it will regulate a few pages later in the guidance: “When the intended use of a mobile app 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 mobile app is a device.” (page 8)

Apps FDA Will NOT Regulate Having defined the mobile medical apps that the FDA intends to regulate, the guidance then presents categories of mobile apps that FDA does NOT consider to be mobile medical apps. FDA does NOT intend to apply its regulatory requirements to developers of these types of apps. (page 4) It is still open for manufacturers who develop these types of apps to request advice from the FDA or to submit the apps to the FDA, but that is not required. The categories include: 1. Apps that provide electronic versions of “medical textbooks, teaching aids or reference materials. (page 10) 2. “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.” (page 11, emphasis added) 3. Apps that automate general office operations.

4. Apps that are not specifically marketed for a medical purpose; e.g., magnification apps that aren’t specifically marketed for people with vision problems are NOT medical apps.3 5. Apps that function as electronic or personal health record systems.

Apps FDA Will Regulate In addition to specifying types of apps that the FDA will NOT regulate, FDA provides examples of apps that they intend to regulate. The examples include: 1. Mobile apps that control “device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.” (page 13) Examples would include apps that cause a mobile device to be used as a remote control for another medical device or displaying images such as an X-ray on a mobile device. 2. “Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.” (page 14) Examples include apps that make use of a mobile device’s built-in accelerometer to “collect motion information for monitoring sleep apnea.” (page 14) 3. “Mobile apps that allow the user to input patient-specific information and - using formulae or processing algorithms - output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.” (page 14) Note that these categories are not intended to be exhaustive, but are merely illustrative. The full scope of the subset of mobile apps that FDA intends to regulate is all apps that meet the definition of a mobile medical app. That definition is supplied earlier in the guidance: “When the intended use of a mobile app 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 mobile app is a device.” (page 8)

IMPLICATIONS
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With all medical devices, it is the intended use that dictates whether a device is regulated. The same is true of mobile medical apps. Among the factors that FDA considers when determining the intended use are the “labeling claims, advertising materials, or oral or written statements by manufacturers.” (pages 7-8) In the context of mobile medical apps, this would include the description of the app provided in marketing materials, the descriptions provided in distribution platforms (e.g., the iTunes store, Android Market, etc.). This would also include the categorization of the app (i.e., whether the app is in the Medical or the Health section of a distribution platform). Apps that are genuinely intended for “general health and wellness” do not generally refer to specific conditions or diseases, such as atherosclerosis or major depressive disorder. Including precise disease state information in the descriptions and promotional materials for an app would certainly be an indication of the intention that the app be used in the “diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease.” (page 8) Requirements for Apps FDA Will Regulate Medical devices fall into three classes (Class I, II, and III). The specific class a device is in depends on its intended use and the risk associated with its use. Class I devices have the lowest risk and correspondingly the least requirements (called general controls), whereas class III devices have the highest risk and the most significant restrictions, including premarket approval. Once a developer determines that an app is a regulated device, the next step is determining the class of the device and what specific requirements apply. As a rule of thumb, any mobile app that replicates the functionality of a medical device that is not a mobile app will have to abide by the same criteria as the nonmobile app version of the device. For example, a mobile app that “analyzes blood glucose readings to help manage diabetes has been classified as part of a ‘Glucose Test System’ under 21 CFR 862.1345.” (page 15) If, however, there is no obvious pre-existing guidance or regulation in place, then it will be necessary to have a dialogue with FDA to determine requirements and ensure compliance.

RECOMMENDATIONS 1. Review existing and planned mobile apps to determine whether they fall under the definition of a mobile medical app provided in this guidance. For mobile apps that do NOT fall under the definition of a mobile medical app provided in this guidance, evaluate marketing materials, descriptions, and category placement in distribution platforms to ensure consistency with the intended use. Specifically, ensure that no marketing materials imply an intended use that would convert the app into a medical device.
2.

For mobile apps that DO fall under the definition of a mobile medical app, determine whether there is a pre-existing non-mobile app that is comparable to the mobile app’s function (e.g., blood glucose test systems) for which FDA has already released regulatory guidance. If that exists, then evaluate your mobile app for compliance with that guidance, and reach out to the FDA to begin the registration process.
3.

If there is NOT a pre-existing non-mobile app that is comparable to the mobile app’s function (e.g., blood glucose test systems) for which FDA has already released regulatory guidance,
4.
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then developers should reach out to the FDA to begin the process of determining what class of device an app falls into and what the corresponding regulatory requirements will be. SUPPLEMENTAL MATERIAL Mobile Medical Applications draft guidance on the FDA website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm2632 80.htm Good Guidance Practices on the FDA website: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=00-23887filed.pdf Premarket Notification Requirements for Medical Devices http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Prem arketSubmissions/PremarketNotification510k/ucm142651.htm ENDNOTES 1. See Good Guidance Practices for details. For example, the Draft Guidance for Industry on Presenting Risk Information issued in 2009 has been viewed by many as codifying and clarifying a view that FDA has been using in its enforcement actions regarding the minimization of risk information for many years.
2.

This follows a well-established principle that a medical device cannot be evaluated independently of its surrounding context. It is the intent to produce a device that has a medical purpose, rather than the device itself, that makes a medical device a regulated entity. See pages 7-8 of the draft guidance and 21 CFR 801.4 for further elaboration of this point.
3.

August 4, 2011

Regulatory Alert: Medical Apps Guidance

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