The imdrf international medical device regulator forum the united states food and drug administration fda and the european commission are aiming for a globally harmonised and consistent approach to increase patient safety and help optimise patient care by.
Fda unique device identification.
Objectives of fda requirements for unique device identification.
830 220 termination of fda service as an issuing agency.
The fda established the unique device identification system to adequately identify medical devices sold in the united states from manufacturing through distribution to patient use.
830 310 information required for unique device identification.
Udi unique device identification overview unique device identification or udi is a new identifying system to be used to identify and mark medical devices within the healthcare supply chain.
830 320 submission of unique device identification information.
Subpart e global unique device identification database 830 300 devices subject to device identification data submission requirements.
The system will work by assigning a unique identifier to most medical devices distributed within the united states.
Unique device identification udi the u s.
The fda is establishing the unique device identification system to adequately identify devices sold in the u s from manufacturing through distribution to patient use.
The global unique device identification database gudid is a database administered by the fda that will serve as a reference catalog for every device with a unique device identifier udi.
The fda released the final rule in.
Food and drug administration fda created unique device identification often abbreviated udi a rule that requires medical device manufacturers to update their products with a unique device identifier that includes both device and production identifiers such as expiration date and lot or serial number.
The global unique device identification database gudid contains key device identification information submitted to the fda about medical devices that have unique device identifiers udi.
