On April 27, 2018, FDA issued draft guidance on Multiple Function Device Products: Policy and Considerations. A multiple function device product contains at least one device function and at least one other function. The guidance clarifies when and how FDA intends to assess the impact of other functions of a medical device that are not the subject of a premarket review on the safety and effectiveness. This guidance stems from the medical software section of the 21st Century Cures Act and is part of the FDA’s long-term Digital Health Innovation Action Plan.
The term “function” is a distinct purpose of the medical device, which could be the intended use or a subset of the intended use of the product. For products containing multiple functions, FDA identifies “other functions” as those that:
- do not meet the definition of device;
- meet the definition of device, but are not subject to premarket review (e.g., 510(k)-exempt); or
- meet the definition of device, but for which FDA has expressed its intention not to enforce compliance with applicable regulatory controls.
In the sponsor’s premarket review submission, FDA recommends separating the device function under FDA’s review from other functions of the device, where possible, because it is easier it is for FDA to independently review the device function. FDA recommends that the sponsor evaluate whether the other function may impact the safety or effectiveness of the device function. And if so, the sponsor should also determine if the impact could result in an increased risk or an adverse effect on performance due to the combination of the other function with the device function-under-review. The guidance identifies additional documentation the sponsor should include in the premarket submission to address any potential adverse impact, or any positive impact that the sponsor would like FDA to consider, including any risk mitigation steps to avoid the potential adverse impact. Where the device function is not adversely impacted by the other function, FDA does not intend to assess that other function in the premarket review.
One example provided by FDA is a smartphone app that would use the camera to take a picture of a suspicious lesion and analyze the photograph to detect skin cancer. The multiple functions would be the device function “analyze” and the other function “take picture.” FDA recommends the premarket submission include documentation to show the evaluation of a potential for an adverse impact between the two different functions. The documentation should detail, for example, the risk mitigation such as error handling to determine if the picture is not adequate for detecting skin cancer, which could result in misdiagnosis. FDA would review the “analyze” function of the app for safety and effectiveness but would likely not review the camera or the smartphone platform.
Readers are encouraged to read the draft guidance, also available on FDA’s website. Comments and suggestions regarding the draft guidance should be submitted to FDA by June 26, 2018.