Open joofio opened 1 month ago
Yes, devices have their own labels as well.
FDA came up with this Unique Device Identifier (UDI) standard. I think this partly describes what would go in the device label and it looks like the DeviceDefinition covers UDI. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
I've never checked to see if UDI and/or the DeviceDefinition covers 100% of the content in a device label. But I would think it was plausible given all that we have achieved with ePI.
Is it plausible to have a similar strucutre for medical devices, is the "epi" mandatory for MD as well? or if not mandatory, do they exist for a considerable amount?
if so, should we change the composition reference to be able to store device/devicedefinition?