- (a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model.
- (b) Compliance with this section does not relieve the labeler of the need to comply with recordkeeping requirements of any other FDA regulation.