Smart Health: FDA Regulation Comes to Silicon Valley
By Emily Krulewitz
In a final guidance titled “Mobile Medical Applications,” FDA put forward its current thinking about regulation of mobile applications that are considered to be medical devices, referred to as ‘mobile medical apps.’ With recent data suggesting that 65% of all Americans own a smartphone it is understandable that the development of mobile apps has progressed in all directions – including towards the health sphere and FDA regulation. While this may surprise some app developers, many of today’s health-related mobile applications do fit under the current definition of a medical device (found in 201(h) of the FD&C Act). That is, the apps are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” FDA’s rigid regulatory requirements are a stark contrast to the relaxed atmosphere of the West Coast, and so Silicon Valley should be seeking out regulatory professionals to help them navigate these new requirements.
FDA divides health-related smartphone apps into three categories:
- Apps that do not meet the definition of a device;
- Apps that do meet the definition of a device but will not be regulated by FDA; and
- Apps that do meet the definition of a device and will be regulated by FDA.
Apps that do not meet the definition of a medical device range widely from apps that provide first-aid information, medical flash cards, information on gluten-free foods, or even directions to the closest medical facility. The Agency acknowledges that these apps do not meet the definition of a medical device and therefore will not be regulated as such.
In its guidance, FDA expresses its intent to use enforcement discretion on many apps that technically meet the definition of a medical device. Most of these apps are designed to help a user self-manage a condition, such as providing motivational guidance for smokers trying to quit or using GPS location to alert asthmatics of environmental conditions that could trigger an asthma attack. Instead of regulating these apps, FDA intends to focus its regulatory oversight on apps where the “functionality poses a risk to a patient’s safety if the mobile app were to not function as intended.”
FDA outlines the three types of apps that the Agency considers to be mobile medical apps and will therefore be subject to regulation:
- Mobile apps that transform a mobile platform into a regulated medical device;
- Mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source; or
- Mobile apps that display, transfer, store, or convert patient-specific medical device data from a connected device.
The first category consists of apps that either use the mobile platform’s built in features (e.g., light or speaker) or an attachment to the platform to perform medical device functions. Some examples would be apps that use a sensor to measure heart signals (ECG), apps that use a laser attachment to treat acne or reduce wrinkles, or apps that use an attachment to monitor blood glucose levels. Apps that fit into the next category could be apps that alter the settings of an infusion pump or control the inflation or deflation of a blood pressure cuff. The last category consists of apps that connect to bedside monitors and transfer data to viewing stations or transfer data from a central nursing station to a physician’s mobile platform for review.
There is some grey area in determining the regulatory status of a potential mobile medical application which relates to the intention of use. For example, the guidance states that mobile apps “that use an attachment to the mobile platform to measure blood oxygen saturation for diagnosis of specific disease or condition” are considered mobile medical apps. At least one pulse oximeter attachment and corresponding app, the iHeath Wireless Pulse Oximeter, has an approved 510(k), though the information on the app store still states the app is for “sports and recreation use only.” Since the guidance specifies that the app should be used for diagnosis of a specific disease or condition, it is unclear if this product truly required FDA approval. Another product, Pulse Oximeter – Heart and Oxygen Monitor, measures heart rate and blood oxygen saturation without using an external attachment and appears to be marketed without an approved 510(k). Even if this app proves to be inaccurate, as some users report, it is unclear if it is legal to market as is or if it needs a 510(k).
The guidance also specifies that mobile apps “that use tools within the mobile platform (e.g., speaker) to produce controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders” would be considered a mobile medical app. The Siemens Hearing Test app is described in the app store as having been “scientifically developed and carefully tested to ensure the most precise results possible” but later it is stated that the “results of the Siemens hearing test are not to be utilized as an official outcome for assessing levels of hearing loss.” Though Siemens is a global company with many FDA-approved medical devices for hearing, this app doesn’t appear to be marketed under an approved 510(k).
Failure to comply with FDA medical device regulations could have serious business and legal repercussions. App developers should seek guidance from a regulatory consultant to determine if any apps in development might be subject to FDA regulations and to assist with compliance. There are still grey areas in determining whether an app meets the definition of a medical device, but that should clear up over the next few years as FDA begins to enforce these regulations. FDA regulation of mobile medical apps is here to stay, and developers must learn to work in tandem with FDA and regulatory professionals to bring their mobile medical app to market.
Emily Krulewitz is a Researcher at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please reach out to us by email.