Robert Belfort, Project HealthDesign Regulatory and Assurance Advisory Group, Manatt, Phelps & Phillips, LLP
Last July, the U.S. Food and Drug Administration (FDA) issued draft guidance on how the agency intended to regulate certain mobile medical applications (apps). My colleague, Deven McGraw, described the guidance in a post last year. The draft guidance sparked heated debate. And some in Congress recently pushed to delay the FDA’s final adoption of the guidance for fear that it might stifle innovation.
The story of Congress’s brush with the proposed guidance is brief but noteworthy. During a Senate Health, Education, Labor and Pensions Committee hearing in April 2012 on the Food and Drug Administration Safety and Innovation Act, the legislation that authorizes the FDA to collect user fees from the companies it regulates, Senator Michael Bennet (D-CO) proposed an amendment that would have placed a moratorium on the FDA’s publication of the final guidance. “I appreciate very much the work the FDA has done to receive stakeholder input, but this interaction between health information and medical devices must be handled delicately. Technology is evolving and being adopted rapidly. I think Congress must provide the proper due diligence on this issue for our constituents, including a number of startups, small businesses, and patients in my home state,” said Bennet as he described his rationale for the moratorium.
Ultimately, Congress passed the Food and Drug Administration Safety and Innovation Act without the moratorium. As enacted, the Act allows the FDA to move ahead with its plans to regulate mobile medical apps while the U.S. Department of Health and Human Services develops a report on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regular duplication.”
Now that the specter of a moratorium is no longer, the FDA is expected to release its final guidance as soon as the end of the year. A brief refresher on the FDA’s regulation of medical devices and on the guidance, as the FDA proposed it in July 2011, is below.
1. Background on the FDA’s Regulation of Medical Devices
A product is a medical device under the federal Food, Drug and Cosmetic Act (the FDCA) if it is “an instrument, apparatus, implement, . . . including any component, part, or accessory, which is . . . [either] intended for use in the diagnosis . . . or . . . cure, mitigation, treatment, or prevention of disease, . . . [or] intended to affect the structure or any function of the body of man . . .” The FDA has stated that for software to fall under this definition, “it is sufficient that it is intended to be used in the process of diagnosis, preventing, or treatment of medical conditions, and it is not necessary that the software actually make or recommend a final diagnosis.” The FDA evaluates intended use by looking at factors surrounding the product’s promotion and distribution.
Vendors of software that qualifies as a medical device must register as manufacturers and list their products with the FDA. The FDA classifies and regulates devices under three categories, according to the amount of potential risk associated with the device’s intended use and indications for use. Class I devices present the lowest risk and are typically exempt from the pre-market submission process, but are subject to general controls required for all devices, including registration, labeling, adverse event reporting, and good manufacturing practices. Class II devices must generally undergo the pre-market notification process. Class III devices are most stringently regulated and require pre-market approval.
2. The FDA’s Draft Guidance on Regulation of Mobile Medical Apps
The FDA’s July 2011 draft guidance document indicated that the Agency intended to apply its regulatory oversight to a subset of mobile apps called “mobile medical apps,” defined as a mobile app that meets the definition of a “device” that either is used as an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device. The FDA proposed to monitor and apply enforcement discretion to other apps that qualify as devices but do not meet the mobile medical app definition; a manufacturer may choose to register and list, and to seek the FDA approval or clearance for such apps.
The guidance also listed certain apps that the FDA does not consider to be “mobile medical apps,” including “mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” Examples of health and wellness apps are provided in the guidance, and include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, etc. In contrast, a mobile medical app is one that is intended for “curing, treating, seeking treatment for, mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.”
As Deven pointed out in her post last summer, the FDA tried to draw clear lines and offered more examples of mobile medical apps in the guidance (see appendix A). However, the distinction between mobile medical apps and health/wellness apps is not always clear. Today, medical conditions are significantly improved — and even prevented — by healthy behaviors, and providers might prescribe or at least recommend particular diet or exercise protocols as part of medical treatment. Many mobile health applications in development and in active use today fall in a gray area between medical and health/wellness. Where do you think the consumer-facing health applications that the Project HealthDesign teams are testing fall?
Comments on the FDA’s draft guidance were due by October 19, 2011 and reports indicate that the FDA received no small amount of feedback. We anxiously await the final guidance and will keep everyone posted.
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