FDA motivated this measure as a security preoccupation in the benefit of the patients. This way, it will be easier to identify, if needed, the people who are using medical devices with potentially functioning issues. It was proved in the past that such situations can occur.
“Up until now, the only products on the market that could not be uniquely identified were medical devices” said after the FDA announcement Josh Rising, director of Pew Charitable Trust.
Because technical solutions will be needed to apply this new FDA requirement, producers will have costs to cover.
