- FDA on Tuesday published final guidance explaining its policies and regulatory review practices for multiple-function device products. Such devices have at least one distinct device function plus one other function that is not the subject of a premarket review.
- The guidance clarifies how the agency intends to assess the impact of those other purposes on the safety and effectiveness of a device function that is under FDA's review.
- FDA published the draft version of the guidance in April 2018. The agency said it incorporated feedback in the final guidance from public comments to clarify and provide examples describing the application of its policies on products with multiple functions. AdvaMed, BD and GE Healthcare were among the industry voices that weighed in.
The 21st Century Cures Act of 2016 excludes certain software functions from the definition of a device but states that FDA may assess the impact of a software function on the safety and effectiveness of a device function. The agency believes this approach should be used to assess all device products that contain multiple functions, whether they are software-based, hardware-based or both.
By way of example, FDA said it does not regulate a general-purpose computing platform but may assess its impact on the safety and effectiveness of a device function under review such as a mobile medical application. Similarly, the agency said, in the case of a product that includes an intragastric balloon and an endoscope accessory like a guidewire that is 510(k)-exempt, FDA may assess the impact of the accessory on the intragastric balloon.
FDA's final guidance also addresses the premarket submission content for device functions under review that are part of a device-, drug- or biologic-led combination product.
The agency advised manufacturers to determine in their risk assessment process whether an “other function” impacts the safety or effectiveness of the device function under review. Manufacturers should provide information only if the function could negatively impact the device function, resulting in increased risk or an adverse effect on performance, or if it has a positive impact that will be represented in the product's labeling.
If the “other function” has no impact on the safety and effectiveness of the device function under review, then the premarket submission for the device does not need to include documentation for the “other function," FDA said.
AdvaMed had requested the guidance clarify that FDA does not intend to review a function just because it is part of a multiple-function device product. The medtech group said it was looking to avoid an inconsistent approach to the review of exempt products, so a reviewer could not find reason to request data previously submitted for exempted functions.
BD, noting that many multiple function device products will contain software, had asked FDA to ensure that the guidance aligns with premarket submission requirements for software contained in medical devices, so that the new guidance does not raise any new requirements.
GE Healthcare, in its comments on the draft guidance, said it thought manufacturers should have the option to submit information relevant to the whole device without distinguishing which function individually meets the definition of a medical device.
In its final guidance, FDA provided seven examples of multiple-function device products to illustrate how assessment of an "other function" would impact a product function under review. The hypothetical examples included a skin cancer detection software application, hand-held coagulation device, a product that determines traumatic brain injury, and a pain treatment app.