FDA issues final guidance on multiple function device products

Regulatory NewsRegulatory News | 28 July 2020 |  By 

A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.
The guidance addresses provisions of the 21st Century Cures Act (Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – and when – FDA will assess the impact of the “other functions” of a product when those functions are not the subject of a premarket review.
“The purpose of this guidance is to identify the principles, premarket review practices, and policies for FDA’s regulatory assessment of such products,” said FDA in the guidance; the guidance also provides illustrative examples of how the policies will be applied.
According to the Cures Act, If a product has a software non-device function and a device function, it is within FDA’s authority to assess how the non-device function impacts the device function, as part of its regulatory function of assessing the safety and effectiveness of the device function. “FDA believes that a similar approach should be used for the assessment of all multiple function device products,” the agency wrote.
“Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not,” explained FDA. For the purposes of the guidance, products that have at least one device function and one non-device function, or “other function,” fall within the definition of “multiple function device products.”
As an example, FDA pointed to a skin cancer detection software application that has a software app that is designed to test skin cancer (the device function-under-review). This app might also need to have a smartphone computing platform, as well as access to the smartphone’s camera – the “other functions.”
In general, FDA will not regulate non-device software functions of products. However, if the other function impacts a device function of the product, FDA may assess the other function’s impact on the device function or functions. “In accordance with existing policies, FDA intends not to review a device function subject to an enforcement discretion policy merely because it is part of a multiple function device product,” clarified the agency in the guidance.
The guidance extends the software-based principles of the Cures Act to other non-software multiple function device products: “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,” according to the agency. The guidance expressly does not provide clarification about what functions do or do not meet the definition of devices.
For premarket assessments, “manufacturers should determine if an ‘other function’ impacts the safety or effectiveness of the device function-under-review,” says FDA, noting that the impact could be negative, as when computing time would be slowed by additional software, or positive, as when processing speed of the device could be improved by other software.
 “Although FDA does not recommend submitting information about all positive impacts from ‘other functions’ in a premarket submission, all impact assessments (negative, positive, and no impact) must be performed and documented as part of design validation,” according to the guidance.
Detailed considerations to assess “other functions” are provided in the guidance, as is a flowchart to aid in assessing the impact of “other functions” on the device function. The guidance also provides points to consider in risk-based safety assessment and any impacts on effectiveness or performance of the device.
When possible, implementing separation and support segregation of device functions can enhance risk control, especially as regards cybersecurity, notes FDA. The agency may request design validation documents as part of its review process.
The indications for use of a product should only include those pertaining to the device-under-review, and not those of any “other function,” unless there is a positive impact that the sponsor would like FDA to consider.
The final guidance, issued jointly by FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiologic Health (CDRH) and Center for Biologics Evaluation and Research (CBER), added to the draft guidance by including considerations for multiple function device products that may be subject to biological license application (BLA) premarket review.
Labeling considerations are also included in this final guidance. FDA notes that “For multiple function device products, the labeling should include a description of the “other function(s)” adequate to ensure appropriate use of the device.
The final guidance also includes recommendations on device hazard analysis and performance testing. Sponsors are also advised when they should consider submitting a 510(k) for changes to the “other function” of multiple function device products.
In addition to the skin cancer detection app example, FDA provides several other illustrations of multiple function device products, walking through how the guidance would be applied to each.


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Tags: device, FDA, medical, US

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