Issued by the FDA last week, the Multiple Function Device Products draft guidance is the latest in a series of recent FDA Guidance documents that reflect FDA’s continued efforts to develop a practical and risk-based approach to regulating medical devices and Digital Health and to interpret the medical software provisions in section 3060(a) of the 21st Century Cures Act (Cures Act).
FDA issued the Multiple Function Device Products draft guidance (Draft Guidance) last week. The Draft Guidance describes FDA’s current approach to regulating digital health tools and medical devices that include both medical device functions and non-medical device functions. This document is the latest in a series of recent FDA Guidance documents that reflect FDA’s continued efforts to develop a practical and risk-based approach to regulating medical devices and digital health and to interpret the medical software provisions in section 3060(a) of the 21st Century Cures Act (Cures Act).
The Cures Act excluded certain non-medical software functions from the definition of “device” under the Federal Food, Drug, and Cosmetic Act (FDCA). However, the rapid growth of integrated medical devices, combination products and digital health solutions that combine multiple components and functions has led to confusion regarding the regulatory status and requirements for certain multiple function devices. For example, the Cures Act excludes most Electronic Health Records (EHRs) from medical device requirements. However, many EHRs contain clinical decision support (CDS) and other analytical functions that may be subject to medical device requirements. The Draft Guidance confirms that FDA intends to regulate only those device functions that are subject to premarket review or other medical device requirements in a multiple function device. The agency, however, plans to evaluate and assess the impact of non-device functions on the safety, effectiveness and performance of regulated medical device functions.
The Draft Guidance clarifies that FDA will not regulate functions of a multi-function device where the “other function” (1) does not meet the definition of a device (including non-device software), (2) meets the definition of a device but not is subject to premarket review (e.g., 510(k)-exempt) or (3) meets the definition of a device but is subject to FDA enforcement discretion. “Function” may be synonymous with intended use, or it may be a subset of the intended use of the system as a whole. FDA also uses the term “device function-under-review” to refer to the functions for which FDA is conducting a premarket review. To this end, FDA encourages sponsors to separate the device function-under-review from other functions in the design cycle and related development processes to the extent possible.
To assess the impact of non-device functions on the function-under-review, FDA plans to consider several factors including, the role of the non-device functions, data inputs and data transfer between regulated and unregulated functions and shared processes such as memory, programming and outputs. The Draft Guidance states, for example, that the non-device function may receive greater scrutiny if it can introduce a hazardous situation or if performance or functionality of the function-under-review depends on the non-device function. Therefore, a premarket submission for a multiple function device should include information about how other functions impact or interact with the function-under-review.
While the Draft Guidance describes a common sense approach to regulating multiple function devices, it raises questions regarding whether and to what extent the function-under-review can truly be separated from other functions. Based on the non-exhaustive list of considerations FDA raises, including shared code, output screens, processing time, memory and system privileges, it seems unlikely that there will be many instances in which FDA is not evaluating the other functions to some degree. FDA’s assessment of the impact and unintended consequences of combining multiple device functions inherently requires a case-by-case, factual evaluation. To assist developers and sponsors in making the initial assessment, FDA provides examples of multiple function devices in Appendix 2 of the Draft Guidance.
Although the Draft Guidance leaves various design, quality and regulatory nuances open to interpretation, it presents a reasonable and useful paradigm for regulating increasingly complex technologies. The public can comment on the Draft Guidance until June 26, 2018.