If you are a developer of apps for a mobile platform, are your apps medical devices, and if so, what requirements do you need to meet? The answer took FDA 43 pages to lay out in their new Guidance for Mobile Medical Applications (here), which was issued on September 25, 2013. And the answer is, well, it depends! As expected, the Guidance indicates that a risk-based approach will be used by FDA in establishing how it will be exercising its enforcement discretion and which areas will be the focus of their regulatory oversight.
This Guidance should not come as a complete surprise to the Industry since it is based largely on the draft Guidance initially issued for comment by FDA on July 21, 2011 (and which resulted in more than 130 comments being supplied to the FDA related to the draft Guidance, according to the Mobile Medical Applications website). Also, as part of the Medical Devices Directive 93/42/EEC, which was revised in Europe effective March 21, 2010, software may meet the definition of a medical device in Europe. The approach of treating mobile medical software as a medical device is not new for the FDA. According to their published data on the Mobile Medical Applications website, FDA has “cleared about 100 mobile medical applications over the past decade; about 40 of those were cleared in the past two years.”
So what does it mean for you? The good news is that most of the apps already available or in development won’t be the focus of FDA’s regulatory oversight. Appendix C of the Guidance may help you to understand where FDA draws the line on whether your mobile medical app is a medical device by providing examples of higher risk apps that FDA determined to be medical devices for which they will provide oversight. It is really amazing the capabilities of the apps that FDA cites in the Appendix – for that reason alone making the Guidance worth the read. For example, mobile medical apps may be classified as medical devices ranging from an electrocardiograph, an electronic stethoscope, a diagnostic tool for hearing evaluations, a controller for activating medical devices (e.g., lasers) and more.
Appendices A and B of the Guidance define conditions where your mobile medical app is not a medical device, or where it may be a medical device, but due to low risk, FDA is not currently planning to enforce requirements under the FD&C Act. If your mobile medical app falls into one of these categories, can you just ignore the Guidance? The answer is once again … it depends. One of the Frequently Asked Questions (FAQs) of note in Appendix F of the Guidance relates to FDA’s recommendation that, even though FDA is not currently planning to enforce requirements under the FD&C Act for certain mobile medical apps that may meet the definition of a medical device, manufacturers should still follow the Medical Device Quality System Regulation and related regulations (discussed below). It is largely a business decision based upon risk factors, such as the nature of your business. Risk factors include:
- Whether you are already an existing medical device manufacturer, in which case you may face more scrutiny
- Whether you have read and interpreted the Guidance correctly
- Whether the FDA agrees with your interpretation
- Potential market experience with your product (Has someone been harmed by it? If so, you may face regulatory oversight regardless of what is written in the Guidance)
What are the implications if your mobile medical app is considered to be a medical device? The question is about as simple to answer as if you had an idea to manufacture any other physical medical device product. The short answer is that your obligations will fall into two buckets, both addressed by the Guidance document.
One bucket relates to your regulatory affairs obligations for the medical device, which likely will require (among many other things) the preparation of the right type of regulatory submission depending upon the nature and risk profile of the product (including but not limited to the 510(k) or PMA submission pathways). Part VI of the Guidance outlines regulatory requirements. Appendices F and G provide answers to FAQs related to the regulatory submission process, and point you to the relevant FDA regulations, guidance and additional resources that you may need. Appendix D lists regulations that may already apply to your device. Also, some elements of Appendix E would likely apply, such as the need for establishment registration, medical device listing, investigational device exemptions (clinical studies), labeling, and pre-market approval/clearance. If your company has never fulfilled medical device regulatory obligations before, the process can be quite daunting. It may be advisable to seek professional regulatory affairs services.
The second bucket is no less daunting of a task – to establish a medical device Quality System. The Quality System Regulation (QSR) and related regulations start at the development stage of products, include manufacturing controls and software validation, continue through to product release, and also extend into the post-market environment, such as systems for collecting, investigating and responding to customer complaints. Appendix E points to the QSR (21 CFR Part 820), as well as to some of the other regulations, such as requirements to submit medical device reports (adverse events reporting) per 21 CFR Part 803 and to conduct and report field corrections (inspection, repair, setting adjustments, software upgrades) or market removals per 21 CFR Part 806. Appendices F and G provide answers to FAQs related to the Quality System and point you to other relevant FDA regulations, guidance and additional resources to which you may need to refer. If your company has never fulfilled medical device Quality System obligations before, it may be advisable to seek professional Quality System/Compliance services.
Note: The FDA Guidance is not intended to be comprehensive (nor is this blog) in listing conditions where your mobile medical application is or is not considered to be a medical device. You should review the full Guidance and contact FDA if there are any questions about whether or not your mobile medical app may be considered to be a medical device. You may also contact Joan Janulis, R.A.C., Vice President, Lachman Consultants (email@example.com) for any questions or concerns relative to Regulatory issues and/or Roy Sturgeon, Ph.D., President, Lachman Consultants (firstname.lastname@example.org) for your Quality System/Compliance-related questions or concerns.