Findings
A “multiple function device product” contains at least one device function and one “other function” that may or may not be subject to FDA oversight.
FDA assesses “other functions” only to the extent they impact the safety or effectiveness of the device function under review or are claimed to provide a positive labeled impact.
Manufacturers must conduct and document risk assessments for all functions within the product to ensure safety and performance.
Functions not directly subject to FDA premarket review are still considered during inspections if they influence the device function under review.
Design separation between device and non-device functions can mitigate risks and simplify regulatory assessment.

Recommendations
Conduct thorough risk assessments for “other functions” and document the impacts, whether negative, positive, or neutral, on the device function under review.
Use design separation to minimize interdependencies between device and non-device functions where feasible.
Include only the relevant “other function” documentation in premarket submissions if it impacts the device function under review or is represented as a labeled positive impact.
For modifications to “other functions,” determine if they significantly affect the safety or effectiveness of the device function, and, if so, submit a new premarket notification as required.
Follow applicable labeling, quality system, and postmarket requirements for both device and non-device functions, ensuring clarity in what has been evaluated by the FDA.

Regulatory Considerations
Non-device functions are not regulated unless they impact the safety or effectiveness of a device function under review.
For device functions under review, manufacturers must comply with FDA’s design validation and risk analysis requirements under 21 CFR 820.30(g).
Changes to non-device functions must be assessed for potential impacts on the device function under review to determine whether additional regulatory submissions are necessary.
FDA evaluates the premarket safety and effectiveness of device functions within the context of interactions with non-device functions but does not directly regulate the non-device functions themselves.
Postmarket requirements, such as adverse event reporting, apply to device functions, including when the event involves an interaction with a non-device function.