Coming off of the Congressional Hearings on FDA regulation of mobile medical apps several weeks ago, mHealth companies increasingly have many questions about what to expect and what they should do to prepare, if and when the FDA’s plan for mobile medical apps is released. The FDA’s Christy Foreman, director of the Office of Device Evaluation, assured Congress during her testimony that the final agency guidance would be available by the end of the fiscal year. A subsequent blog post by Foreman discussed release of the guidance “in the coming weeks.”
Although companies have been anticipating the final guidance since the draft was released in 2011, planning for the imminent release is now more important than ever. With those concerns in mind, here's a list of the top 10 issues that companies should be thinking about between now and release of the final guidance.
1. Scope of FDA regulation
Foreman’s testimony during the recent Congressional hearings suggests that in the almost two years since release of the agency’s draft guidance, the FDA’s basic policy on mobile medical apps has stayed generally the same. Based on her testimony, I expect that the subset of apps the agency will regulate will likely be very similar to those outlined in the draft guidance. That is good in the sense that it doesn’t appear that the FDA plans to greatly expand their oversight beyond what they said in 2011.
However, the number of existing or planned apps that are likely to fall into the FDA’s subset may still be quite large. In her Congressional testimony, Foreman noted that the agency has reviewed approximately 100 app products to date. However, because there has been little enforcement activity in this space since the 2011 guidance (see #10 below), this most likely represents only products from companies that have come forward to work with the agency. There are numerous products available today that may fit within the scope that the FDA has proposed. There is hope from many in the industry that clarification in the final guidance may better define the edges of what is regulated and give companies a clearer idea of whether their product is in or out.
2. Health and wellness vs. medical devices
One of the areas where clarity is needed relates to health and wellness apps targeted at specific patient populations. The draft guidance planned to exempt from regulation apps that are used for general health and wellness purposes, such as apps that track fitness goals or provide dietary recommendations. The FDA explained that those products are not generally intended for treating or diagnosing specific patient conditions. But what if the app provides dietary recommendations for patients with diabetes? Traditional medical device thinking would hold that if the product is intended to be used by a patient population with a specific medical condition, in essence serving as part of the plan for mitigating the condition, then it would probably be a medical device. The draft guidance didn’t address this specific scenario of health and wellness apps targeted at specific patient populations. Unless the final guidance gives us greater clarity on this particular point, this could pull in many mHealth products that companies were expecting to fall outside the FDA’s scope.
3. Accessories
In the draft guidance, the FDA defined a mobile medical app as an app that meets the definition of a medical device and either (1) is used as an accessory to a regulated medical device; or (2) transforms the mobile platform into a regulated medical device. Historically, accessories to a regulated medical device are put into the same classification as the “parent” medical device. Thus, right now, if an app were an accessory to a class III product, then the app would also be class III, no matter how simple and low risk.
But this may change. In the Federal Register preamble to the mobile medical apps guidance, the agency recognized that some accessories may be much lower or higher risk than their parent device. The FDA went on to lay out a rough proposal for regulating apps consistent with their risk profile, rather than the risk profile of the parent device. If the FDA follows through on developing a different approach, then it could make things much easier for companies with low-risk apps that associate with high-risk medical devices. By the same token, it could make things harder for companies with an app pulling from a class II medical device, like some imaging equipment, that is then used in a more high-risk way, such as automated cancer screening. Such an app could potentially trigger a higher classification. It remains to be seen whether the FDA will make any changes based on the plans outlined in the preamble, but it could be a real game changer.
4. Connections
Closely related to the issue of accessories is the question of where the regulated stream ends. The draft guidance talks about accessory apps as “connected” to the parent device. But in the world of mHealth, everything is connected to everything else. Clarification from the FDA is needed on when a connection to a regulated product triggers regulation and when it does not.
For example, imagine that app A is “connected” to a blood pressure cuff and app B connects to app A. Assuming for a moment that app A is serving as an accessory to the blood pressure cuff, is app B also an accessory to the blood pressure cuff or to app A? The most conservative view would be that both apps are potentially regulated (assuming they otherwise meet the definition of a medical device). The FDA could really help the mHealth space by clarifying this issue. Since the FDA was already thinking about accessory regulation, there is some hope that clarity may come with the final guidance.
5. Clinical decision support tools
One of the big FDA regulatory issues that has been developing parallel to the mobile apps guidance relates to regulation of clinical decision support tools. In fact, that was the focus of one of the FDA’s sessions during the public workshop on mobile medical apps back in 2011. The draft mobile apps guidance itself talked about apps that “allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.” This obviously could be interpreted to cover a whole host of products that are in development or already in use. While there is some precedent for regulation of products meeting this definition, many such products have developed outside of the influence of FDA regulation.
CMS Meaningful Use criteria have significantly increased the reliance on and interest in clinical decision support tools. Meanwhile, although the FDA has indicated interest in these products, the agency has not mapped out what would be required in order to achieve clearance or approval of such tools. For example, would the FDA regulate the content of such systems, requiring that companies demonstrate that the recommendations are associated with improved outcomes, or would reliance on evidenced-based medicine be sufficient?
The FDA has indicated that the agency is separately working on a clinical decision support guidance document, but unlike the mobile medical apps guidance, a guidance addressing clinical decision support is not on the agency’s list of priorities for 2013. Hopefully, if the FDA keeps this category in the draft mobile medical apps guidance, the agency will also provide some direction to companies about the path to market.
6. Non-mobile applications
Although the focus over the last few years has been largely on applications developed for mobile platforms, the FDA has historically regulated functionality, not platforms. Thus, the fact that the FDA’s draft guidance only talks about products intended to run on a mobile platform does not mean that the same functionality running on a PC or on a web page won’t be regulated. This is not at all clear from the draft guidance, nor is it clear whether the exemptions that the FDA carved out in the draft guidance for certain types of apps would also apply to applications made for non-mobile platforms. Generally, if functionality is of a type that meets the definition of a medical device, regulation should be expected regardless of which platform runs that functionality.
7. Pathway for regulated apps
There are certain types of apps and standalone software products that have been regulated for years and for which the regulatory pathway is well understood. For example, there are numerous 510(k)-cleared apps or software tools that help patients track their glucose readings or calculate insulin doses. However, in a space where innovation is paramount, there may be many apps that fall into the scope of FDA regulation, but for which there is no clear regulatory pathway.
Medical devices are generally regulated according to a risk-based classification, where class I products typically may be introduced to the market without prior clearance or approval from the FDA. Similarly, most class II or III products require clearance or approval prior to marketing. The classification depends on the risk associated with a particular product, but knowing which class your product falls into requires reliance on FDA classification regulations and precedent.
For example, there is a regulation dictating that a scalpel is a class I medical device. But for products that are novel, there may not be any applicable classification regulations. The general consensus appears to be that many apps are likely to be handled as class II products. But in order to get 510(k) clearance, a company needs to make an argument that the new product is “substantially equivalent” to an existing product. The alternative is known as a Direct De Novo petition, but that pathway tends to be less well-defined and is often associated with the need for supporting clinical data. The FDA’s guidance did not address the classification of these apps. Absent further clarification in the final guidance, companies that fall into the regulated space will need to consider and plan for the pathway that will get them to FDA clearance.
8. Quality system compliance
Much of the discussion regarding FDA regulation in this space relates to the need for companies to seek FDA clearance or approval prior to marketing. But for mHealth companies that have already moved into the FDA-regulated space, one of the biggest challenges has been compliance with the FDA’s Quality System Regulation (21 C.F.R. Part 820). The regulation requires that, absent an exemption, companies making regulated medical devices must have an FDA-compliant quality system in place that is then subject to inspection by the FDA every few years or so.
Foreman’s Congressional testimony, as well as the questions raised by members of Congress, focused on the impact of FDA regulation on speed to market. But the need to develop and manage a product under a compliant quality system can also have a significant impact on the way a company does business, particularly when it comes to software. The FDA’s requirements were written for traditional medical devices where modifications are made much less frequently than for software products. Some medical devices are exempt from compliance with the quality system requirements, and the FDA could take that approach for certain types of apps, but companies should be aware that the FDA’s regulation will also likely affect the way that a product is managed after it goes to market.
9. Changes to regulated products
Similar to the issues associated with Quality System compliance, it is important to understand that once a class II product is cleared by the FDA, a company must consider whether any change made to the product triggers the need for a new 510(k). Many changes do not require a new 510(k), but a company is expected to assess each change individually, as well as in the aggregate, and those assessments should be documented in the company’s regulatory files. This process, like compliance with the quality system requirements, has been managed by medical device manufacturers for decades, but may be an adjustment for companies new to FDA regulation.
10. Enforcement
Since the draft mobile medical apps guidance was issued in 2011, there has been almost no public regulatory enforcement activity by the FDA. In 2011, the FTC stepped in to stop the distribution of two apps designed to treat acne, but FDA activity has been fairly non-existent. This is not uncommon when the agency is in the process of developing a new policy.
The mHealth space, however, has continued to evolve at a rapid pace, and the existence of the 2011 draft guidance has created a great deal of uncertainty about companies’ existing obligations. Generally, many expect that enforcement will increase as soon as the final guidance is released, but how is not clear. Recent conversations with FDA staff suggest that the final guidance may not result in sudden, large-scale enforcement activity and that the agency may try to work with companies to increase compliance.
For products with clear FDA precedent, companies cannot necessarily rely on the absence of final guidance to avoid regulation. It is fair to expect that when the FDA does take enforcement action, the agency may start with products it considers to be clearly regulated. For example, the draft guidance specifically notes that drug dose calculators are already regulated by the agency. Companies making such products, whether in app form or otherwise, may not want to wait until final guidance is issued before considering their regulatory action plan.
In conclusion, these 10 issues summarize the key questions that will likely come up again and again as companies in the mHealth space plan for the future. While we wait for the final guidance, it is worthwhile for companies to take time to understand these issues and develop an action plan for complying with FDA regulatory obligations.
Yarmela Pavlovic is a partner in Hogan Lovells’ Life Sciences practice. Her practice focuses primarily on the U.S. Food and Drug Administration (FDA)'s regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices. She has extensive experience in assisting companies in matters pertaining to product development and product submissions (510(k)s, IDEs and PMAs), as well as providing advice on a variety of other device-related regulatory issues.
