On July 29, 2020, the US Food and Drug Administration (FDA) issued guidance for industry and FDA staff regarding multiple function device products, updating draft guidance released in 2018.1 The term “multiple function device product” means any product with one or more functions that are subject to FDA regulatory oversight as medical devices and other functions that are not. Product functions are considered medical devices if they meet the definition of a “device” under the federal Food Drug and Cosmetic Act (FDCA), while other functions are not regulated as devices either because they do not meet that definition or because FDA has indicated it will exercise enforcement discretion with respect to that function.
The guidance document contains nonbinding recommendations that represent the “current thinking” of FDA. The agency notes that one may use “an alternative approach” if it satisfies the requirements of applicable laws. Readers may submit comments and suggestions for FDA’s consideration at any time, which may be used to develop further guidance.
FDA’s new guidance adds to its growing policy library addressing digital health, including the agency’s “Policy for Device Software Functions and Mobile Medical Applications” released last year.2
Under Section 201(h) of the FDCA, a “device” is defined as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
The 21st Century Cures Act (the “Cures Act”), signed into law on December 13, 2016, amended the definition of “device” to expressly exclude certain software functions. These exemptions from regulation as a device include certain software functions intended (i) for administrative support for a health care facility, (ii) for maintaining or encouraging a healthy lifestyle (such as general “wellness” apps), (iii) to serve as electronic patient records, (iv) to transfer, store, convert, or display clinical laboratory test or other device data and results and certain related information or findings by a health care professional, or (v) to provide limited clinical decision support to a health care professional.3
The Cures Act also addressed products with both a “device function” that meets the definition under the FDCA, as well as other software functions that do not. For such products, the Cures Act provides that FDA “shall not regulate” the software functions that are outside of the definition of “device,” but may consider their impact on the “device function” in assessing its safety and effectiveness.4
Under the new guidance, FDA clarifies that its assessment will focus on the impact of any non-device functions on the safety and effectiveness of the device function, including analyses of whether the functions could be successfully partitioned and whether any potential impact would produce adverse or beneficial results. In addition, depending on the potential impact of other functions on the product’s device function, the regulated party may be required to take further action such as including additional content as part of a premarket submission, submitting a new 510(k), or modifying the device’s description or labeling.
FDA’s guidance provides several sample analyses, including a Transcutaneous Electrical Nerve Stimulation (TENS) device controlled by a mobile phone software application on a Bluetooth-enabled mobile platform worn by the user to treat pain, as well as an app that uses a mobile device camera to detect skin cancer.
Digital health devices, while a primary focus of the Cures Act and this guidance, are not the only products impacted. FDA’s guidance further clarifies that although the Cures Act specifically addressed products with a device function and a non-device “software function,” FDA believes the “same principles should apply to the assessment of all multiple function device products, whether those functions are software-based, hardware-based, or both.”
FDA’s new guideposts for assessing regulation of multiple function device products should prove useful to those attempting to navigate the rapidly evolving regulatory landscape for digital health technologies and devices. For assistance in this regard, please feel free to reach out to any of the Dentons attorneys included on this notice.