FDA Mobile App Guidance Focuses on Risk, Calls for “Enforcement Discretion”

Sept. 30, 2013 – Pharmaceutical companies that develop mobile applications should pay close attention to the details and examples listed in the FDA’s final guidance on mobile medical applications (MMAs), which was issued Sept. 25.

The final guidance on Mobile Medical Applications – a primer on how the agency plans to approach software programs that run on mobile communication devices and perform the same function as traditional medical devices – states that the agency intends to exercise “enforcement discretion (meaning it will not enforce requirements under the Federal Food, Drug & Cosmetic Act) for the majority of mobile apps” and will focus its oversight on MMAs that “present a greater risk to patients if they do not work as intended,” an FDA press release states.

“FDA clearly did the right thing deciding NOT to regulate the vast majority of mobile apps,” said Coalition for Healthcare Communication Executive Director John Kamp. “This guidance will enable mobile app innovation to develop at Net Speed, measured in moments and days, rather than Government Speed, measured in years and decades.”

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said FDA Director of the Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, M.D., J.D. The agency reports that it has approved roughly 100 MMAs during the past 10 years, with 40 of those approvals occurring within the last two years. “To place that in context, there are over 100,000 apps available in the broader category of health and wellness today,” a Digital Health Coalition press release states.

The final guidance looks a lot like the draft guidance the agency circulated in July 2011, but there are several important changes that marketers of pharmaceuticals should note, according to Dale Cooke, Vice President/Group Director, Digitas Health.

One type of application that should be closely monitored is a dosing application, he said. The FDA provides an example – an app that uses patient-specific parameters to calculate dosage or create a dosage plan for radiation therapy – and states that mobile apps become a regulated medical device by performing patient-specific, sophisticated analysis and providing patient-specific diagnosis, or treatment recommendations, according to the guidance.

However, Cooke explained, the agency also cites an exemption later in the document which states that apps that “perform simple calculations” are not subject to device filing requirements. “It’s going to require some time for marketers and pharmaceutical regulatory professionals to get comfortable with the distinction between these types of dosing decisions and [how to determine] whether your app uses a ‘sophisticated analysis’ or a ‘simple calculation’ to determine appropriate dosing,” he told the CHC.

Digitas Health recommended in a Sept. 24 regulatory alert that companies take the following steps in light of the final guidance:

  • Evaluate existing plans for mobile apps, placing special emphases on Appendix A (examples of mobile apps that are not medical devices) and Appendix B (examples of mobile apps for which FDA intends to exercise enforcement discretion);
  • If a planned or existing MMA falls under an area where FDA will be applying regulatory oversight, companies should begin a dialogue with the FDA about the appropriate registration pathway;
  • If it is unclear whether the agency will be applying regulatory oversight to a mobile app, companies should follow the procedures outlined in Appendix F (frequently asked questions), up to and including filing a 513(g) Request for Designation with CDRH to determine the class and any regulatory restrictions that apply to an MMA.

Although the agency’s statement in the final guidance that it will use regulatory discretion is “a very welcome clarification” that “will make perfect sense to regulatory professionals, marketers may be confused by the concept,” Cooke stated. “When FDA asserts that it will exercise regulatory discretion in a certain area, it is stating that [it] has the legal authority to enforce regulations, but that it is choosing not to do so,” he explained, because many of these devices pose a low risk to patients.

“There was much confusion from the draft version of the guidance because there seemed to be a large number of apps that met the definition of a medical device as the FDA was interpreting it, but where its oversight seemed unnecessary,” Cooke added. “In the final version, the FDA is clarifying that it agrees and will only exercise its regulatory authority in areas where patient safety is at risk.”

According to Jeffrey K. Shapiro, writing in the Hyman, Phelps & McNamara FDA Law Blog, “This general approach makes sense, because FDA and industry both have limited resources, so it is realistic to apply the expensive and burdensome FDA regulatory system only to mobile apps that pose a significant risk to patients.  In technical regulatory terms, this approach is known as getting the most bang for the buck.”

Shapiro also summarized which types of apps are and are not included, noting that apps that perform patient specific analysis and provide patient specific diagnosis or treatment recommendations are considered MMAs. “This last type of mobile medical app looks very much like clinical decision support software (‘CDSS’),” Shapiro stated. “However, FDA expressly says that this guidance does not address CDSS. FDA is expected to issue a draft guidance on that topic in the near future,” he noted. To view the full blog entry, go to: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/mobile-medical-applications-a-thoughtful-guidance-is-finalized.html