Rather than reviewing the impact of every device contained in a multiple-function device product, FDA only intends to assess the device function-under-review.

On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to the manufacturing and marketing of “multiple function” device products—products comprised of at least one FDA-regulated “device” function and at least one “other function”—a function that either does not meet the definition of a “device” under the Federal Food, Drug & Cosmetic Act (FDCA); that is not subject to premarket approval; or for which the FDA has expressed an intention not to enforce regulatory compliance.

An example of a multiple-function device product used in the guidance is a smartphone software application (i.e., a mobile app) that detects skin cancer from photos of suspicious lesions or moles. Whereas the device function-under-review (the FDA-regulated device function for which clearance or approval is being sought) is the software app that detects skin cancer, the other functions include the smartphone computing platform and the camera on the computing platform. Though not subject to FDA regulation on their own, the other functions impact the device function-under-review; for instance, the software app depends on the smartphone camera for photos and the computing platform for analysis.

Under the FDCA, other functions are not automatically subject to FDA review simply because they are part of a multiple-function device product. However, FDA is permitted to assess impact of those other functions under certain circumstances. The guidance addresses the situations in which FDA intends to review the impact of such other functions on the safety and effectiveness of the device function that is subject to FDA review and contains recommendations concerning how manufacturers can adequately prepare for such review.

Scope of Review

Rather than reviewing the impact of every device contained in a multiple-function device product, FDA only intends to assess the device function-under-review. Consequently, the guidance recommends that manufacturers of multiple-function device products should determine whether any other function impacts the safety or efficacy of the device function-under-review, whether the impact is negative (e.g., the other function adversely affects the performance of the device function-under-review by slowing down processing speed) or positive (e.g., the other function enhances the safety and efficacy of the device function-under-review by improving processing speed). In their premarket submissions, manufacturers are encouraged to provide information related to the impacts of the other functions only if they (a) could negatively impact the device function-under-review or (b) positively impact the device function-under-review and this positive impact will be represented in the proposed labeling.

Recommendations

Based on FDA’s intentions for reviewing multiple-function device products, the guidance outlines a number of considerations for manufacturers of such products. For example, FDA recommends that the device function-under-review should, to the extent possible, be separated from the other functions in design and implementation in terms of logical separation and architectural separation as well as code and data partitioning. Further, according to FDA, manufacturers should consider the effects of other functions, including their role in the performance of the device function-under-review; any limitations of the device function-under-review when using the other function; how to ensure that appropriate actions are taken by the end user when using the device function-under-review with the other function, etc.

Assessment of Impacts

The guidance explains that, in conducting its premarket review of a product with multiple functions, FDA will first assess whether there is any impact on the safety or efficacy of the device function-under-review as a result of the product’s other functions. The determination of whether any other function may impact the safety or efficacy of the device function-under-review should include consideration of whether the other function provides input data used for a critical calculation within the device function-under-review; whether the device function-under-review relies on results from the other function; whether the other function and the device function-under-review share the same output screen or graphical user interface, etc.

If FDA finds that there is any impact in its preliminary review, the agency will determine whether the impact could result in increased risk or have an adverse effect on the performance of the device function-under-review. With respect to safety considerations, if the impact yields no increased risk, no additional mitigation is necessary. If there could be increased risk, the risk should be adequately documented and mitigated, and the appropriate verification or validation should be performed to ensure that the mitigation is effective. As for effectiveness, such impacts are typically to the performance of the device (i.e., impacts to the responsiveness, usability, or efficiency of the device).

Additional recommendations and qualifications concerning FDA’s policy on multiple-function device products are contained in the guidance, available on the FDA website.

For More Information

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