Can Your App Avoid FDA Regulation? 4 Questions to Ask

By Keith Barritt


Should you submit your app for FDA clearance? Keith Barritt of Fish and Richardson, a law firm specializing in medical device-related litigation, offers some quick tips to guide you.

The Food & Drug Administration’s 2013 guidance on mobile medical apps limits the agency’s regulation to apps that both (1) fit the definition of “medical devices” and (2) whose functionality could pose a risk to a patient’s safety if they do not function as intended.
A “medical device” is defined as anything that is intended to diagnosis a disease or condition, to cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body (without relying on chemical action or metabolization, which would make the product a drug). The “intended use” of an app is therefore critical to determining if it is a regulated medical device.
Keith Barritt will be speaking at MD&M East on "Regulatory Mobile Medical Devices: Overcoming Local and Global Challenges" June 10, 2014  
1.) Does your app transform a platform into a medical device?
An app that turns a smartphone itself into a device, such as software that allows the smartphone to be used as a stethoscope, will be regulated in the same manner as the device the platform is transformed into.
2.) Does your app control another medical device?
An app that can be used to control a medical device, such as bytransmitting control signals to an insulin pump, will be regulated in the same manner as the device it controls.
3.) Does your app perform patient-specific analysis, diagnosis, or treatment recommendations?
Examples include apps that use patient-specific parameters to calculate dosage or create a dosage plan for radiation therapy or image processing software (however, the FDA’s guidance specifically does not address the approach for software that performs patient-specific analysis to aid or support clinical decision-making).
If you answered YES to any of these questions, you should submit your app to FDA.
4.) Does your app fall into a gray area?
FDA says it intends to exercise “enforcement discretion” and not regulate mobile apps that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining “general fitness, health or wellness,” even if marketed, promoted or otherwise intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. What constitutes “general fitness, health, or wellness” is still somewhat of a gray area, especially considering that FDA said in the same breath that it will exercise enforcement discretion even if the app is also intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The FDA did give the following examples of apps that it would not regulate:
  • Tools to promote or encourage healthy eating, exercise, weight loss or other activities generally related to a healthy lifestyle or wellness;
  • Dietary logs, calorie counters or making dietary suggestions;
  • Meal planners and recipes;
  • Tracking general daily activities or making exercise or posture suggestions;
  • Tracking a normal baby’s sleeping and feeding habits;
  • Actively monitor and trending exercise activity;
  • Helping healthy people track the quantity or quality of their normal sleep patterns;
  • Providing and tracking scores from mind-challenging games or generic “brain age” tests;
  • Providing daily motivational tips (e.g., via text or other types of messaging) to reduce stress and promote a positive mental outlook;
  • Using social gaming to encourage healthy lifestyle habits;
  • Calculating calories burned in a workout.
Determining whether a particular mobile app is a regulated medical device can be tricky business. App developers who sell outside the United States should also be aware that while many countries focus on the intended use of the product to determine its regulatory status, that is not the case everywhere. Some regulatory agencies focus instead on the actual potential use or functionality of the product, regardless of the marketing claims. Thus, before introducing an app that arguably has medical uses, care should be taken to ascertain its regulatory status under local law.
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Keith A. Barritt is a Principal in the Washington, DC, office of Fish & Richardson. In 2014, he was recognized by World Trademark Review 1000 for trademark prosecution and strategy in the DC Metro area. Mr. Barritt has prepared and filed dozens of 510(k) pre-market notifications with the FDA to obtain marketing authorization for various types of medical devices, ranging from innovative lasers to software-based surgical devices.