FDA Mobile App Guidance Finalized

September 24, 2013 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
The Food & Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued the finalized version of the Mobile Medical Applications guidance.1 The final version of the guidance largely confirms the approach FDA initially presented in the draft version from July 2011.2 There are, however, some important changes; and marketers of pharmaceuticals, in particular, will be affected by some of the places where additional elaboration and clarification has been provided. In light of the finalization of this guidance, Digitas Health recommends companies take the following actions: 1. Evaluate existing plans for mobile applications (apps) in light of the finalized guidance. Special emphasis should be focused on Appendix A that discusses the apps FDA does not consider to be medical devices and on Appendix B describing the mobile medical applications (MMA) where FDA intends to exercise regulatory discretion* (i.e., intends to not exercise regulatory oversight). 2. If a planned or existing MMA will fall under an area where FDA intends to apply its regulatory oversight, then begin a dialogue with FDA about the appropriate registration pathway. 3. If it is unclear whether the MMA is one where FDA intends to apply its regulatory oversight, follow the procedures outlined in Appendix F up to and including filing a 513(g) Request for Designation with CDRH to ask FDA to determine the class and consequently the regulatory restrictions that apply to an MMA.

BACKGROUND
The draft version of this guidance was released in July of 2011. Since then, it has become a subject of intense speculation and concern both within industry and in the halls of Congress. There are many differences between the draft version and the final version of the guidance, but the overarching regulatory framework remains the same. Apps that meet the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)3 are potentially subject to FDA regulatory oversight and/or enforcement, including the possibility of premarket submission to FDA via either a 510(k) or PMA submission. But FDA makes clear that it intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patients safety if the mobile app were to not function as intended.4

Discretion is used here in its technical definition. FDA is asserting that it has the legal authority to exercise enforcement against this group of apps but is publicly stating that it will not take such actions. Members of industry who were concerned about the ambiguity in the draft guidance will be pleased that FDA is definitively establishing the position that it will not take enforcement action.

RELEVANT FACTS & IMPLICATIONS

The final guidance includes a far more elaborate discussion of the distinction between MMA where FDA intends to focus its regulatory oversight and those where it intends to exercise regulatory discretion (i.e., where FDA does NOT intend to pursue enforcement action) because FDA sees these apps as relatively low risk. FDAs Regulatory Focus FDA intention to focus its regulatory oversight is largely unchanged from the draft guidance. Just as in the draft version, FDA indicates that it will regulate apps that are intended: to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.5

FDAs elaboration on this is similar to the presentation from the draft guidance. Again, FDA focuses on three types of MMA: 1. Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. 6

These types of apps might control another medical device remotely, such as the ability to control inflation and deflation of a blood pressure cuff.7 MMAs such as this are accessories to the primary device with the same regulatory requirements as the base device. FDA also notes that the connection between the devices does not have to involve a physical wire but can include wireless connectivity.8 2. Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.9

MMAs in this category include modifications to a mobile device such as plugging in a sensor that enables a mobile device to function as a stethoscope using the mobile devices microphone and speaker functionality.10 3. Mobile apps that become a regulated medical device (software) by performing patientspecific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.11

This third category of apps that will receive regulatory focus explicitly includes apps that use patientspecific parameters and calculate dosage or create a dosage plan for radiation therapy.12 Where Regulatory Discretion Applies Whereas the discussion of the apps FDA intends to regulate is largely unchanged from the draft guidance, the discussion of the MMA where FDA intends to exercise regulatory discretion is significantly expanded. In the

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Regulatory Alert: Mobile App Guidance Finalized

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draft guidance this discussion was limited to footnote 13, and that footnote achieved a moderate degree of fame as commenters debated its scope and import.13 FDA clarifies in the final guidance that it intends to exercise this discretion for apps that: Help patients (i.e., users) 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 Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.14

Many typical patient adherence and support programs developed by pharmaceutical companies and provided via apps would fall into these categories, and FDAs final guidance makes clear that such efforts can proceed without fear of facing enforcement for violating the FD&C. In addition to the list of features quoted above, FDA also provides two appendices with six pages of listings of apps that FDA either does not consider to be medical devices, and which thus, do not qualify for FDA regulation or that fall within the category where FDA will exercise regulatory discretion.

RECOMMENDATIONS
In light of the finalization of this guidance, Digitas Health recommends companies take the following actions: 1. Evaluate existing plans for mobile applications (apps) in light of the finalized guidance. Special emphasis should be focused on Appendix A that discusses the apps FDA does not consider to be medical devices and on Appendix B describing the mobile medical applications (MMA) where FDA intends to exercise regulatory discretion (i.e., intends to not exercise regulatory oversight). If a planned or existing MMA will fall under an area where FDA intends to apply its regulatory oversight, then begin a dialogue with FDA about the appropriate registration pathway. If it is unclear whether the MMA is one where FDA intends to apply its regulatory oversight, follow the procedures outlined in Appendix F up to and including filing a 513(g) Request for Designation with CDRH to ask FDA to determine the class and consequently the regulatory restrictions that apply to an MMA.

2.

3.

Guidance for Industry: Mobile Medical Applications, last accessed from http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM26 3366.pdf on September 24, 2013. Hereinafter, Final Mobile App Guidance. 2 For a more extended discussion of the draft guidance, see Digitas Health Regulatory Alert: FDA Draft Guidance on Medical Apps Released, published August 4, 2011. Last accessed May 28, 2013 from http://www.scribd.com/doc/61645605/Regulatory-Alert-Medical-Apps-Guidance-Digitas-Health-August-2011 3 This definition is excerpted in the guidance. Quoting the relevant portion, medical devices are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of

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disease, in man or intended to affect the structure or any function of the body of man or other animals . (Final Mobile App Guidance, page 7, footnote 4) 4 Final Mobile App Guidance, page 13. 5 Final Mobile App Guidance, page 12. 6 Final Mobile App Guidance, page 14. 7 Final Mobile App Guidance, page 14. 8 Final Mobile App Guidance, page 14, footnote 22. 9 Final Mobile App Guidance, page 14-15. 10 Final Mobile App Guidance, page 15. 11 Final Mobile App Guidance, page 15. 12 Final Mobile App Guidance, page 15. Dosage calculators more generally would seemingly fall within this category. It is, however, worth noting that FDA explicitly mentions in the discussion of apps where it will withhold regulatory enforcement those apps that perform simple calculations routinely used in clinical practice (Final Mobile App Guidance, page 17). Sponsors unclear whether their dosage calculation falls under the area of regulatory focus or discretion should ask FDA for an explicit determination. 13 See, for example, Thompson, Bradley Merrill, FDA (Finally) Returns Industrys Calls for Mobile Medical Apps Guidance last accessed from http://www.mddionline.com/blog/devicetalk/fda-finally-returnsindustrys-calls-mobile-medical-apps-guidance#! on September 24, 2013. 14 Final Mobile App Guidance, page 16.

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