FDA 21 CFR 801.45 (a) states:
"A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use."
Couple quick questions:
1. So "direct marking" is synonymous with "permanent marking", and by "permanent marking" this means some kind of etching or engraving? I presume an indelible label is inadequate?
2. What is the definition of "reprocessing"? Does it include basic cleaning or disinfecting (e.g. simple wipe-down with an alcohol swab)?
"A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use."
Couple quick questions:
1. So "direct marking" is synonymous with "permanent marking", and by "permanent marking" this means some kind of etching or engraving? I presume an indelible label is inadequate?
2. What is the definition of "reprocessing"? Does it include basic cleaning or disinfecting (e.g. simple wipe-down with an alcohol swab)?