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Three Cheers for FDA Mobile App Guidelines

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Background

On September 25, 2013, the FDA released an official guidance for its approach to reviewing and regulating healthcare-related mobile apps. Granted the world did not stop turning that day, but for those of us in pharmaceutical advertising it is still an important moment. We now have parameters to use when discussing whether to build an app for a client and what it could do. There is still a lot of grey area in the discussion, but the guidelines make it possible to evaluate how the FDA could respond and to engage with MLR teams to make an app a reality.

Specifics

As expected, the agency believes that certain apps qualify as medical devices and, as such, fall under FDA oversight. It is critical to understand when the agency will enforce that oversight to guide and shape the development of any health- or product-related mobile app by a pharmaceutical company.

The guidance first distinguishes between general health apps and apps whose intent, functionality and impact on patient health classify them as Mobile Medical Apps (MMAs) that the FDA intends to provide oversight of within the existing regulations for medical devices.

The FDA will apply its regulatory oversight to an app that meets the definition of a medical device (section 201[h] of the Federal Food, Drug, and Cosmetic Act) and either is designed or intended to:

1. Be for used in the diagnosis or the cure, mitigation, treatment, or prevention of disease
2. Affect the structure or any function of the body
3. Be used as an accessory to a regulated medical device
4. Transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods regardless of the mechanism behind the transformation. (1)

The key words are “design” and “intent.” The FDA will look at the intent as indicated in communications around and within the app as well as the design and functionality to determine classification. The FDA is particularly concerned with MMAs whose functionality could pose a risk to a patient’s safety if the app were not to function as intended. The guidance noted that some MMAs may meet the definition of a medical device, but because they pose a lower risk to the public, the FDA intends to exercise oversight discretion. Examples of such apps include designs that:

1. Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions
2. Provide patients with simple tools to organize and track their health information
3. Provide easy access to information related to patients’ health conditions or treatments
4. Help patients document, show, or communicate potential medical conditions to health care providers
5. Automate simple tasks for health care providers
6. Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems

Evaluation

The new guidance aligns with previous FDA communications about medical devices and mobile apps, although it does seem to broaden the areas in which the FDA will apply oversight discretion vs. automatic regulation. While this is welcome breathing room for pharmaceutical brand teams to explore the creation of a mobile app, the guidance does underscore the importance of early discussions between marketing and medical/legal/regulatory teams to define and solidify the intent and functionality of an app to appropriately determine a classification and subsequent FDA oversight approach.

The level of regulatory oversight is dependent on the classification of the app, which can only be fully evaluated with intent and functional specifications clearly defined. RTC recommends marketing teams review any app design and intent with medical/legal/regulatory teams early in the development process to determine the potential classification and required steps with the FDA.

The discussion should include:

1. App design and high-level functional requirements
2. Potential risk to patients in the case that there is a flaw in functionality
3. Potential marketing communications and messages that indicate intent and use of the app

Full guidance: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm

(1) Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services, Food and Drug Administration, September 25, 2013

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