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In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions.

It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the FDA sent out a public warning to health care providers and people with diabetes of risks associated with use of MMA devices for diabetes management that had not been reviewed by the FDA. The FDA has received reports of serious adverse events in which patients used unauthorized devices that receives the electronic signal from an FDA authorized glucose monitor and converted it to a glucose value using an unauthorized algorithm. This error in the algorithm has caused Glucose values gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system. This unauthorized system resulted in an insulin overdose requiring medical intervention. A medical regulatory consulting firm can help.

So what makes a piece of software for mobile devices a medical device? An MMA is considered a medical device if it 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 other animals. Companies that sell MMAs need to be aware that the intended use is not determined solely by the indications for use statement or intended use statement that the company provides. Intended use can also be revealed by labeling claims, advertising materials, or oral or written statements by the manufacturer or its representatives.

Here’s an example: an app that measures heart rate and displays the data on either a smartphone or transmits the data to a remote computer server. The app shows this message on the smartphone display every time the app is used: “This app is intended to monitor heart rate for use as a health and fitness tool.”

Given that statement, this app is not a medical device because heart rate monitoring is a common tool for fitness training and the intended use statement clearly makes no medical claims. However, if the company produces sales and marketing material that suggests heart rate information can be sent to a physician or other healthcare professional, or the information can be used to identify arrhythmia, the FDA can determine that the software is now an MMA and a medical device. In this case, the company must have quality system development.

To further complicate the compliance waters, software developers not usually in the business of creating healthcare-related products may have greater difficulty interpreting medical device regulations and run afoul of compliance issues that can delay a product and significantly increase costs. Even when they do understand that they are making a medical device, they do not document the development of the product correctly creating long, undue delays with medical regulatory submissions.

According to the FDA, a software developer creating a MMA is considered mobile medical app manufacturer when they:

  • Create, design, develop, label, relabel, remanufacturer, modify, or create a mobile medical app software system from multiple components
  • Initiate specifications or requirements for mobile medical apps or procures product development/manufacturing services from other individuals or entities for subsequent commercial distribution.
  • Create an MMA and hardware attachments for a mobile platform that are intended to be used as a medical device by any combination of the MMA, hardware attachments, and the mobile platform.
  • Create an MMA or software system that provides users access to the medical device function through a website subscription, software as a service (SaaS), or other similar means.

The FDA regulates three basic categories of MMAs as follows:

  • Mobile apps that are an extension of one or more medical devices by connecting such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.
  • Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.
  • Mobile apps that become regulated medical device software) by performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations. These types of MMAs are similar to or perform that same function as those types of software devices that have been previously cleared or approved.

As the MMA market expands and evolves, it is clear that there must be a healthy marriage between innovation, appropriate quality controls throughout the MMA lifecycle towards a medical regulatory submission: 510(k), De Novo or PMA submissions that fulfill regulatory compliance while allowing for product claims. This will enable future development of MMAs to take place efficiently and cost-effectively. That is why working with a medical regulatory consulting firm like MEDIcept to help ensure they avoid any compliance setbacks

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