In a Sept 23, 2013 Press Release the FDA announced that the final guidance for mobile medical applications has been issued. This much anticipated guidance, aimed squarely at developers of apps for smartphones and tablets, will likely generate quite a bit of enthusiasm in the Twittersphere and other social networking sites frequented by techies. The agency received over 130 comments on the original draft of this guidance, which was released for public review in July 2011. As noted in the Press Release, the regulatory approach to mobile medical apps documented in this final guidance implements a tailored, risk-based approach by the FDA, which is intended to support innovation in mobile healthcare, while applying regulatory oversight to those apps which may pose a greater risk to patients if the apps do not work as intended.
Let’s review a few key highlights related to final guidance and the associated FDA announcements:
- Based on industry estimates, the FDA anticipates substantial continued growth in the use mobile healthcare applications, with 500 million smartphones users worldwide using a health care app by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded a mobile health application.
- By taking a risk-based approach to the regulation of mobile medical apps, the FDA intends to apply its regulatory oversight to a small subset of the thousands of currently available or future mobile health apps. As an indication of the intended scope of the final guidance, the FDA has stated that, to date, approximately 100 mobile medical apps have been cleared, with 40 or so in the past two years. It is expected that a greater number of mobile medical apps will be regulated by the FDA as the technology becomes more pervasive, but the number of these apps will be a small percentage of the overall app types available.
- As defined in this final guidance, the FDA is focusing its oversight on mobile medical apps that either (1) are intended to be used as an accessory to a regulated medical device or (2) transform the mobile platform into a regulated medical device. An example of an app of type (1) above is a smartphone-based viewer of medical images generated from a picture archiving and communication system (PACS). An example of an app of type (2) above is a smartphone-based electrocardiograph using an ECG lead attached to the phone, which is running ECG analysis software.
- A very useful aspect of this final guidance is the extensive use of examples of types of apps that would fall into different regulatory categories. These examples are extremely helpful in determining whether or not your app would require FDA clearance. Regulatory categories illustrated with multiple examples include Appendix A – Examples of Mobile Apps that are not medical devices, Appendix B – Examples of Mobile Apps for which the FDA intends to exercise enforcement discretion and Appendix C – Examples of Mobile Apps that are the focus of FDA’s regulatory oversight. This information is very helpful to those app developers who have little or no familiarity with FDA regulations.
- Finally, of great interest to medical device regulatory professionals, the guidance confirms that no additional regulations are required for mobile medical apps, and that the regulatory focus for these type of devices continues to be on the functionality and intended use of the app, and not the platform technology. Appendix E of the guidance lists the existing device regulations that would likely apply to mobile medical apps, including 21 CFR Part 807 Establishment Registration and Listing, 21 CFR Part 812 Investigational Device Exemptions, 21 CFR Part 801 Labeling, 21 CFR Part 809 IVD Products, and 21 CFR Part 820 Quality System Regulations/GMPs.
This 43 page final guidance for Mobile Medical Applications is well written and is directly applicable to the emerging mobile health care technology. Mobile app developers and medical device regulatory professionals will find this guidance useful, especially with the extensive lists of examples of various mobile app types. The guidance presents a well-balanced and reasonable FDA approach for regulating Mobile Medical Apps and considers the need to foster and support innovation in this new technology, as well as focusing on those types of apps that may pose a risk to the public health. Just like Goldilocks, the FDA’s approach to the regulation of Mobile Medical Apps is “Not Too Much, and Not Too Little, but Just Right!”