What is a Multiple Function Device?

What this episode covers

Mike Drues from Vascular Sciences explains the regulatory framework for multiple function devices, defined as products containing both regulated medical device functions and non-regulated consumer functions. He analyzes FDA guidance using examples like smartphone skin cancer apps and handheld coagulation devices to show how non-device components are indirectly reviewed through risk mitigation. Drues advises manufacturers to decouple functions for individual risk assessment before evaluating the integrated system, and strongly recommends seeking pre-submission meetings with the FDA to align on strategy.