MDDS (Medical Device Data System)
When you use a Bluetooth connection as part of your diagnostic or treatment medical device, how do you separate the various components to avoid including “off the shelf” designs (Class I) in your Class II medical device?Yet, in some designs where Bluetooth pairing is part of the wireless coexistence, an MDDS device can morph into a Class II medical device and bring undesired performance requirements and testing.
Review the MDDS guidance from FDA/CDRH to identify what is Class I and what is Class II.
MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements.
