Are you thinking about developing a mobile app for a healthcare application? Using mobile apps as part of your “medical device?” While most mobile apps will not be considered part of the FDA’s jurisdiction, there are some that will fall under it’s regulatory oversight. They’ll be apps that can pose a risk to a patient’s safety if they don’t work right. If this applies to you, you’ll want to review the new “Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff.” It’s a non-binding review of the FDA’s latest thinking on the subject.
There is no firm FDA regulatory policy for software at this time, but certain types of software are already classified as medical devices for regulatory purposes. These products are either part of a software/hardware bundle (like EKG machines) or are only software products (laboratory information management systems, for example). And the rule of thumb in classifying software as a medical device is the functionality to analyze medical device data.
So you’ll find that if the app you’re developing or have in production either analyzes medical data and/or could harm the patient should it malfunction, you have what’s being called a “Mobile Medical App.”
This guidance document is primarily concerned with identifying 3 types of application types for FDA purposes. First would be applications that are not medical devices. Then the FDA divides applications that may be mobile medical apps into 2 groups: Ones that they intend to focus regulatory attention on, and ones they don’t.
Much of this document is devoted to definitions. These definitions help you to understand one group from the next. And the balance of the document is then directed towards how the FDA intends (at this point) to monitor them. The discussion covers only the basics of FDA oversight. So for example, you’ll get some information on the three tier classification structure for medical devices — Class I, Class II and Class III — and the various regulations that apply to each.
To support the lengthy discussions of how to determine what app falls into which of the 3 regulatory categories, there are 7 Appendices provided. Appendix A, B and C give examples of mobile apps that are:
- not medical devices,
- those that are but will get FDA discretion when it comes to enforcement,
- and those that will be the focus of the FDA’s regulatory efforts.
Appendix D covers examples of current regulations. Appendix E gives a description of some regulatory requirements. Appendix F is a series of FAQ’s. And Appendix G has additional resources listed, primarily the various standards that are applicable to this topic.
If you review this guidance document and don’t find a reference to an application that is similar to yours, you’ll probably want to check in with the FDA to see if it falls within their jurisdiction. And if your medical device has a software component that you’ve not considered to be covered by FDA oversight yet, you may want to review this document as well. It has a lot of information on the parameters you’ll want to consider when evaluating the applicability of these regulations to all types of software components.
If your products are covered by FDA regulations or if you’re in the medical device field and want a standards supplier that can support all your standards and regulatory compliance needs, do consider Document Center. We have a wide range of documentation available, well monitored, to provide you with complete support. You can purchase the documents you need at our web store, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re your Standards Experts!
