Regulation of Medical Apps by the FDA: What qualifies as a “medical app”

By Alexis Fotiu and Bronwyn Spira PT

The number of medical apps that can be found in the App Store is increasing exponentially as healthcare professionals realize the benefits these apps provide patients. There are currently over 38,000 health and fitness apps and over 24,000 medical apps available today (1). This comes as no surprise since consumers are becoming increasingly interested in tracking and managing their health through their mobile devices. 19% of smartphone owners have downloaded an app to track or manage their health and 41% have a strong interest in remote monitoring devices to check conditions and send information to their doctor (1). According to Research2Guidance, 500 million smartphone users worldwide will be using a health care application by 2015 (1).

The vast number of medical apps available can be overwhelming to consumers. As we covered in our previous blog post, “Beware of Fraudulent Medical Apps,” not all medical apps are trustworthy, which is why the FDA has put together the Draft Guidance for Industry Food and Drug Administration Staff –Mobile Medical Applications.

Mobile medical apps are not a new focus for the FDA—about 100 mobile medical apps have been reviewed since 1997 (2). However, with over 24,000 medical apps how will the FDA keep up with the constant innovation and new releases of apps? In the final congressional hearing on FDA regulating medical apps, a representative for the FDA responded to this question saying “We get about 20 a year right now. That is 0.5 percent of the medical devices we get in our 510(k) process each year (2)”. Many companies planning to introduce a medical device to the US market need to submit an application to the FDA called a 510(k). A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device that is not subject to premarket approval. 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements (3).

On their website, the FDA issued the following statement:

The FDA encourages further development of mobile apps that improve health care and provide consumers and health care professionals with valuable health information quickly. The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of medical applications with a clear and predictable outlines of our expectations. (4)

In the final congressional hearing on FDA regulating medical apps, Christy Foreman, (Director Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration), stated it takes about 67 days on average for mobile medical apps to get FDA approval through the 510(k) clearance system (2).

The Draft Guidance states that the FDA intends to apply its regulatory authority to mobile apps that are medical devices under the current definition: an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or function of the body and either transforms smartphones or tablets into a medical device (as defined above) or is used as an accessory to a medical device (as defined above). (1)

This definition can cause confusion and introduces a gray area—a mobile app that meets the definition of a medical device but is not necessarily transforming a mobile platform into a medical device or acting as an accessory to a medical device, and hence is not a “mobile medical app” (1). For now, developers can classify their apps using the following criteria:

Mobile medical app:
• Control a medical device or display, store, analyze, or transmit patient-specific medical device data
• Attachment, display screen, or sensor that transforms a mobile device into a medical device
• Diagnosis, treatment recommendations, or clinical decision support applying formulae or algorithms to patient-specific inputs (1)

Some examples that FDA is trying to regulate? Foreman says it has been regulating apps for a decade. Apps that translate heart rate, SpO2, ultrasound technology that allows transducers to plug into an iPhone. – these types present patient risk (2).

The three classes of FDA regulated medical devices:

In the final congressional hearing on FDA regulating medical apps, Foreman stated they have not yet encountered a Class III mobile medical device (2).

Not a medical app if:
• Electronic reference materials
• Training materials
• Log, record, track evaluate, or make decisions related to general health and wellness
• Healthcare administration, including billing, appointments, and insurance transactions
• EHRs or PHRs
• Generic aids not marketed for medical indication (1)

Which apps will the FDA not regulate? Foreman says an e-version of a textbook. If risk is low, FDA would rather focus on higher risk ones. Pedometers, for example, will not be regulated (2).

Undoubtedly the FDA will continue to alter their guidelines and introduce new standards as they navigate through regulations and are introduced to new medical apps. Prior to the release of the Draft Guidance the FDA encouraged everyone to send comments and suggestions regarding the guidelines so they could take every position under consideration—developers, patients, healthcare professionals—so they could implement guidelines that ensure safety but don’t inhibit innovation and advancement in the delivery of healthcare.

As any new regulations will, the Draft Guidance has received opposition and uncertainty from those feeling it will hinder development and innovation. As stated by in an article on MobiHealthNews, “For mobile apps FDA regulates, the quality system requires that manufacturers use rigorous design controls to document and organize the software development process. But that’s not how app developers have traditionally operated, and this requirement potentially slows down development to a snail’s crawl (5)”. For some the new regulations may deter them from even considering developing a new app due to clearance or approval uncertainty.

Others view it as a benefit—providing a safety net for users who depend on these apps for accurate information and analytics. By providing these regulations, the FDA is attempting to prevent medical apps with fraudulent content from being available to users.

“For a huge percentage of digital health companies, following FDA regulations will actually make them a better company, with a higher quality process, and open the door to the entire healthcare market, including enabling them to bid on contracts with some of the largest government institutions. Entrepreneurs should embrace, not fear, the FDA (1) ” – Geoff Clapp Co-Founder and Former CTO Health Hero Network, Mentor, Rock Health

Foreman says the final guidance will come out in the coming months and is a priority for the FDA (2).

Sources

1) Ghandi, Malay, and Deborah Pascoe. "FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health." A Rock Report by Rock Health. Rock Health. 2013. Lecture.

2) Dolan, Brian. "Liveblog: Day 3 Congressional hearing on FDA regulating apps." MobiHealthNews. Chester Street Publishing, Inc., 21 Mar 2013. Web. 4 Apr 2013. <http://mobihealthnews.com/21142/liveblog-day-3-congressional-hearing-on-fda-regulating-apps/8/>.

3) "Device Approvals and Clearances." U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 18 Jun 2012. Web. 4 Apr 2013. <http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/default.htm>.

4) "Mobile Medical Applications." U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 22 Dec 2011. Web. 4 Apr 2013. <http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ucm255978.htm>.

5) Merrill Thompson, Bradley. "After FDA’s mobile medical apps final guidance, what’s next?."MobiHealthNews. Chester Street Publishing, Inc., 26 Mar 2013. Web. 4 Apr 2013. <http://mobihealthnews.com/21252/after-fda’s-mobile-medical-apps-final-guidance-what’s-next/>.