On Feb. 9, the US Food & Drug Administration released guidance documents related to what kind of Mobile Medical Apps it will regulate, and what types that it won't. The FDA explained that "the rapid pace of innovation in mobile apps, and the potential benefits and risks to public health" warranted the new guidance.
The most notable outcome: A mobile app that serves as an accessory to support, supplement, or augment an existing medical device, or to transform a mobile platform into a regulated medical device is now considered an FDA-regulated mobile medical app.
The good news is that by saying which apps it will regulate the FDA makes clear that some digital health apps, wearables, and software are exempt from regulation. This opens up plenty of opportunities for developers of "general wellness" apps to move ahead without the complication of applying for FDA 510(k) certification required to market a medical device. Here are three key questions facing developers of health-related mobile apps that the FDA addresses:
What Are Mobile Medical Apps?
The FDA is focusing its attention on the small subset of mobile medical apps that meet the definition of a medical device and that are intended for use as accessories to regulated medical devices, or intended to transform a mobile platform into a regulated medical device. Moving forward, consumers will use both regulated mobile medical apps and more general consumer mobile apps to manage their health and wellness. Other apps aim to help healthcare professionals improve and facilitate patient care.
Which Mobile Apps Will Not Require FDA Regulation?
For many mobile apps that meet the regulatory definition of a "device," but that pose minimal risk to patients and consumers, the FDA won't expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile apps that:
- Help patients/users self-manage diseases or conditions without providing specific treatment suggestions.
- Provide patients with simple tools to organize and track their health information.
- Provide access to information related to health conditions or treatments.
- Help patients document, show, or communicate potential medical conditions to healthcare providers.
- Automate simple tasks for healthcare providers.
- Enable patients or providers to interact with personal health records (PHR) or electronic health record (EHR) systems.
Mobile apps used in the production process for medical devices, or for collecting, storing, and maintaining quality system data for medical devices (including complaint submissions) are not considered medical devices on their own. Therefore, they're not considered mobile medical apps, but are part of the quality system that requires compliance with the appropriate good manufacturing practices regulations.
What Mobile Apps Will Require FDA Regulation?
The FDA plans to apply regulatory oversight only to those mobile apps that are medical devices and whose functionality could pose a risk to a patient's safety if they were not to function as intended.
It will regulate mobile apps that connect to a medical device in order to control the device, do active patient monitoring, or analyze medical device data. The mobile medical app would face the same regulations applicable to the connected medical device. Mobile apps that use attachments, display screens, sensors, or similar components to transform a mobile platform into a regulated medical device face scrutiny as well.
The FDA will also treat mobile apps performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations as regulated devices.
As mobile apps continue to evolve in the world of healthcare, app designers will face more scrutiny than ever. Some will do their best to avoid designing an app that will require registration with the FDA. Others will push forward because they know they are providing a service that helps clinicians and their patients. Will it be worth their investment in time and money? I think so. Disruptive change can be painful, but in the end, if we improve patient care, we'll have accomplished what we set out to do.
Through our Innovation Lab in Newport Beach, Calif., we are developing several apps -- some that fall into the exempt mobile app category and others in the mobile medical app category that will need to be registered with the FDA. FDA registration adds one more obstacle to an already challenging process to take a product to market, but that's the price of doing business in the healthcare innovation space.