In a previous post on this site I discussed my reasons for endorsing FDA oversight of mobile medical apps. Since we are nearing a final decision by the FDA concerning the matter, I thought it fitting to bring it to the attention of those not familiar with the issue and to bring it up to date for others. According to a recent presentation by the FDA to the Regulatory Affairs Professional Society there are now 17,828 health and fitness apps and 14,558 medical apps. It is my intent to review in as basic a manner as possible the presentation. In doing so, I believe I might clarify some misconceptions and highlight areas of focus for more examination. I also think this might alleviate some anxiety of those who have not read the complete FDA Draft Guidance on Mobile Medical Apps issued on July 21, 2011. Seminal to discussing the role of the FDA in regulating apps is the review of some basics. The FDA defines a mobile medical app as:
“…a mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent…..”, that is “…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man…”); and either: is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device. The intended use of a mobile app determines whether it meets the definition of a ‘device’…”
According to the FDA, its scope will be “mobile medical apps that are either traditional medical devices or a part of or extension of a traditional medical device.” ‘Enforcement discretion’ will be exercised for “self-management apps” and “simple tracking or trending apps not intended for treating or adjusting medications.” There will be no regulatory requirements for apps not considered “mobile medical apps.”
Feedback focused on three areas of the draft guidance document: the scope of mobile medical apps, accessories of medical devices, and software for clinical decision support. With regards to clinical decision support, important things to be considered are the potential level of impact on a subject or disease and the ability to identify errors in informational input or output and clinically wrong information. The FDA has also discussed releasing draft guidance with respect to software that are accessories to medical devices and for clinical decision support. In addition, ‘enforcement discretion’ will need to be clarified in my opinion. There have been some interesting comments by observers in the EU on the FDA Draft Guidance. Generally, there seems to be a prevailing opinion that they might adopt much of the FDA Guidance’s framework.
As with any policy or legislation, the devil is in the details. The proposed establishment of a separate division of the FDA for the regulation of mobile medical apps has been made. I applaud this suggestion for a number of reasons. It will employ experts in software, mobile health technologies and healthcare IT, not presently organized in the present FDA. Having a separate division will hopefully streamline the review process. This separate division will also be more receptive to changes in regulatory issues which will undoubtedly exist in this new realm of healthcare technology regulation.
As this process unfolds, it is my hope that the excellent feedback from industry experts and others on the Draft Guidance, the subsequent comments from the FDA, and the attention this issue has received from the press and legislators will result in a regulatory framework which both protects patients from harm and developers from undue burden.