Mobile health apps and products have transformed the way people monitor their well-being, providing a convenient way to track vital signs and daily activity, and they have the potential to do much more in the clinical setting. As these apps have become a daily fact of life for many, they also raised urgent questions for regulators striving to ensure public safety and for the manufacturers who must adapt to these rules. Both sides must address concerns like how to define a "medical app" and determine which ones have the potential to endanger consumers.
The prospect of dealing with the complex web of laws and forms involved in seeking U.S. Food and Drug Administration approval can be daunting to many business leaders. However, consulting the guidance laid down by the agency will help app makers understand what is expected of them and strategize accordingly. All manufacturers of innovative medical products should be aware of how the FDA approves or clears health apps and the effects this could have for the medical device development process.
"The FDA distinguishes among types of devices and apps."
How the FDA classifies health apps
Mobile apps include any software run on devices like smartphones or computers.The FDA makes several important distinctions among different types of devices and apps. Knowing how the agency takes these variations into account when making decisions about approving or clearing mobile apps helps businesses arrive at more informed decisions about product design and functionality. The key definitions laid out in the guidance on mobile health apps include the following:
- Regulated medical devices include a wide range of machines, software or apparatus used to diagnose, monitor or treat diseases, injuries or handicaps or provide contraception.
- Mobile medical apps are mobile apps that are also medical devices.
- Low-risk general health apps are noninvasive and intended to promote wellness but not to treat any particular disease or condition.
What devices require FDA approval?
The rules applied to mobile health apps are based around the apparent level of risk presented by each product. Medical devices the FDA characterizes as risky or invasive must be approved. Devices the agency does not consider to present a potential danger to users may be considered exempt from review or be cleared on the basis that they are sufficiently similar to a product already on the market.
The FDA does not currently require reviews before going to market for apps that perform functions such as:
- Offering basic tools to keep track of health data.
- Giving users information about health conditions or treatments
- Helping users manage a disease or condition without offering specific suggestions for treatment.
- Documenting signs of a potential medical condition for a patient to share with a doctor.
- Automating routine tasks for healthcare professionals.
- Allowing patients or healthcare providers to interact with electronic health record systems.
In these and other cases, the agency has determined apps and devices present little danger to users. Writing for the FDA Voice blog, Bakul Patel, associate director for digital health in the FDA's Center for Devices and Radiological Health, and Dr. Jeffrey Shuren, director of the CDRH, stated the agency's reasoning.
"Through these actions, we continue to clarify which medical devices are of such low risk that we will no longer focus our regulatory oversight on them or we will regulate them under a lower risk classification, narrowly tailoring our approach to the level of risk to which patients or consumers are exposed," they wrote.
What FDA guidance means for your product
While finding out what regulations apply to new products and ensuring compliance can be a long and complicated process, mobile health app makers do have significant advantages thanks to these measures. The FDA has left plenty of room for businesses to experiment with intriguing new avenues in medical device design and development. Brad Thompson, an attorney experienced in helping medical device manufacturers work through federal regulations, commented on this approach to VentureBeat.
"FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software," Thompson said. "It's exciting, because it means that innovation in this space can truly flourish."
While there is a great deal of leeway in how the FDA currently treats mobile health products, these rules can still have a meaningful impact on how medical device development goes forward. One important issue to keep in mind is the level of limitations placed on the claims manufacturers can make. For instance, while an app meant to support general wellness can be said to promote maintaining a healthy weight, the maker should not claim it can treat or diagnose a medical condition like obesity or anorexia.
Furthermore, completing extensive paperwork and undergoing the process of approval or clearance can still be difficult and time-consuming, especially if the FDA has not considered similar devices in the past. At every stage, it's vital to seek expert guidance and legal advice to achieve the best outcome for the next generation of breakthrough medical products.