Posted by: adelvecchio
applications, FDA, Medical device regulation, Medical devices
Guest post by Zachary Landman, M.D., chief medical officer, DoctorBase
Of the more than 80,000 health related applications available on the App store and Google Play, fewer than 100 are Food and Drug Administration (FDA)-approved mobile apps. Though some health apps will meet the criteria to be considered a medical device (or an accessory to one) outlined in the FDA guiding document released in September, the vast majority will not. That is a significant problem for many app developers who often work independently, in small teams and are often based overseas. Before costs are even considered, most app developers looking to enter the healthcare market have very little idea about how medical devices classes are classified, marketed, tested, and approved.
There are three medical devices Classes, I, II, and III, ranging from devices with the least harmful potential to the greatest. Class I medical devices typically are hospital items such as dialysis chairs, beds, assisted mobility devices and the like. Very few medical apps will land in this category since most apps don’t work in this manner and the lowest risk medical apps such as pill reminders or communication tools are currently exempt from FDA classification as medical devices. Class I medical devices are relatively quickly and easily approved (more than 97% of Class I applications are approved).
Furthermore, Class I devices are exempt from filing a 510(k), which refers to a section of the Food, Drug, and Cosmetic Act that requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance of doing so. Examples of some Class I apps that have been approved include a patient bed monitoring app, a battery powered examination light, a magnifying app, and a medical image storing app. None of these apps collect or interpret vital information such as blood pressure, visual acuity, hearing, heart rate, or breathing function.
The vast majority of regulated medical apps including all those in the “smartphone physical” category will likely fall into Class II. Class II devices are those in which “general controls” are insufficient to ensure the safety and effectiveness of its use. This means that malfunctioning or improper reporting of the device could lead to injury or harm to the user or patient. Some examples of mobile medical apps that fall into this category that have received approval include apps that can measure pulmonary function (spirometry), blood pressure (an app that regulates inflation and recording of measurements from the cuff), and stethoscopes.
The vast majority of these apps will require a submission of a 510(k) as well as sufficient clinical and/or laboratory information that documents the efficacy, precision, and accuracy of the data that the app collects, transmits, and records. While there is a publically available list of Class II devices which have earned exemption, the standards and classification systems used previously for exemption (nasal cannula, knob to control oxygen flow) may not translate as well to clinically relevant medical apps. Preparation and approval for Class II devices takes between three and six months at a minimum and often costs tens of thousands of dollars for preparation and submission alone.
Class III devices are those in which error can lead to serious harm to human life. Examples include pacemakers, automatic external defibrillators, and HIV diagnostic tests. To my knowledge, no medical app to date has been approved as a Class III device likely due to the time and investment required to meet FDA standards. In the United States, approval can take between 18 and 36 months depending on the availability of clinical data and the initial completeness of the pre-market approval, which is a more stringent version of the 510(k).
Since no medical apps now (or in the very near future) are likely to be approved as Class III, I won’t go into greater detail. However, one can imagine in the coming years an influx of apps that can control ventilation machines, interrogate and correct pacemaker issues, and interact with other types of implantable devices, such as knee replacements or neurologic stimulators. These devices will require significant investments in both time and capital.
So, while the FDA guiding document is largely hands-off and provides incredible leeway for consumer-directed and inter-provider health apps, those that will gather, analyze, or automate data may find themselves with significant hurdles to clinical implementation in the coming years. It should be noted, FDA approval is not a one-time expense, but requires dedicated personnel and processes for adverse event recording, reporting, and correcting following approval. Therefore, at least in healthcare, the most influential apps are unlikely to be coming from a few developers subsisting on Ramen and pizza, but from a coordinated effort between existing industry players and app development companies.
Zachary Landman, M.D., is the chief medical officer for DoctorBase, a developer of scalable mobile health solutions, patient portals and patient engagement software. He earned his medical degree from UCSF School of Medicine. As a resident surgeon at Harvard Orthopaedics, he covered Massachusetts General Hospital, Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center.