10 issues that mobile medical app developers should keep in mind
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testimony during the recent Congressional hearings suggests that in the almost two years since release of the agency’s draft guidance, the FDA’s basic policy on mobile medical apps has stayed generally the same.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I expect that the subset of apps the agency will regulate will likely be very similar to those outlined in the draft guidance.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 The draft guidance planned to exempt from regulation apps that are used for general health and wellness purposes, such as apps that track fitness goals or provide dietary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.