FDA released guidance explaining how medical device manufacturers can start adding a UDI to their devices. The system is meant to reduce medical errors, and speed up the process in discovering device errors.
There is much more to come from FDA by way of regulatory interpretation and we intend to track it.This is the first of a series covering our thoughts on the current Unique Device Identifier (UDI) program. We first provide a basic overview and then drill down a bit more in future installments, offering some practical […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.