In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software.
The FDA’s General Approach to Regulating mHealth Products
Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. Food and Drug Administration (FDA) regulation as a medical device. If so, developers must develop and execute on a regulatory strategy.
Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. A medical device is statutorily defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is generally intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body of man or other animals. A medical device does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and is not dependent upon being metabolized for the achievement of its primary intended purposes.
The FDA regulates mHealth technologies that are medical devices, but the agency has adopted a risk-based approach to regulating mHealth technologies, such as medical device software. This means that, when the FDA considers how to regulate mHealth devices, it is considering the risk the device software poses to consumers when it is used. Specifically, the FDA is considering the potential harm to a consumer should the product fail to work as intended. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device. If, however, an mHealth medical device fails and it’s of little danger to the consumer, the FDA may not expend resources regulating the product, even if the agency could do so because the product fits the statutory definition of a medical device. This approach is known as exercising enforcement discretion.
When assessing mHealth technology, the FDA will determine whether an application is either:
i. not a medical device,
ii. a medical device, but one for which the FDA intends to exercise enforcement discretion (and not actively regulate),
iii. a medical device subject to FDA oversight and enforcement.
The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. The FDA has opined on several categories of mHealth: general wellness devices, mobile medical applications (MMAs), and clinical decision support (CDS) software.
General Wellness Products
The FDA defines general wellness products as products that are intended only for general wellness use, e.g., maintaining or encouraging a general state of health or encouraging a healthy lifestyle to help reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that healthy lifestyle choices impact outcomes, and present a low risk to the safety of users and other persons. Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act. Therefore, the FDA does not regulate general wellness mHealth products.
Mobile Medical Applications
MMAs are software programs that incorporate device software functionality and run on, for example, Smartphones. When an MMA is used for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the human body, the MMA is a medical device subject to FDA regulation and enforcement, e.g., software functions that act as wireless remote controls or synchronization devices for computed tomography (CT) or X-Ray machines. At the other end of the spectrum, there are MMAs that do not meet the definition of a medical device and are, therefore, not regulated by the FDA, e.g., educational tools for clinicians or patients, medical flash cards, surgical training videos, assistance for patients looking for potentially appropriate clinical trials, or information about gluten-free food products.
Under the FDA’s risk-based approach, even if an MMA meets the definition of a medical device, the device may not be subject to FDA oversight and enforcement if the device presents a low risk of harm to patients should the medical device malfunction, e.g., software functions that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider. In these cases, the FDA will exercise enforcement discretion.
Given that the FDA has opted to exercise enforcement discretion for lower risk medical devices, developers may have a hard time determining when a mobile application is or is not subject to FDA oversight and enforcement. The FDA’s guidance documents on General Wellness and Mobile Medical Applications provide numerous examples of products that are and are not actively regulated and enforced by the FDA. When in doubt, counsel may be able to assist with an analysis of the applicable regulatory requirements, or developers may request a determination from the FDA directly by submitting a request for information in accordance with Section 513(g) of the FD&C Act (21 U.S.C. 360c(g)). This process provides a means for obtaining the agency’s views about the classification and the regulatory requirements that may be applicable to a particular device. More information about this process may be found in FDA’s 513(g) Guidance Document.
About the author
Kyle Faget is a partner and business lawyer with Foley & Lardner LLP. She is the Co-Chair of the firm’s Health Care Practice Group, Co-Chair, Health Care & Life Sciences Sector – Medical Devices, and a core member of the firm’s life sciences and telemedicine industry teams. Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.
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