FDA Issues Guidance on Multiple-Function Devices

The FDA has clarified its regulatory approach for multiple-function devices in a final guidance that outlines the extra steps manufacturers of such products need to take.

The guidance covers devices that have several functions, some of which are software capabilities that may fall outside the agency’s regulatory purview but may still affect the safety and effectiveness of the device’s medical purpose.

If the device’s medical effectiveness could be compromised by its non-medical functions, the manufacturer should carry out “appropriate verification and validation” of the possible adverse effects on the device’s medical performance, the agency says.