Fda 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.

Fda unique device identification.

Subpart e global unique device identification database 830 300 devices subject to device identification data submission requirements. 830 310 information required for unique device identification. The fda released the final rule in. 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.

Unique device identification udi the u s. 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. Objectives of fda requirements for unique device identification. A unique device identification udi system is intended to provide single globally harmonized positive identification of medical devices through distribution and use requiring the label of devices to bear a globally unique device identifier to be conveyed by using automatic identification and data capture and if applicable its human.

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 system will work by assigning a unique identifier to most medical devices distributed within the united states. The establishment and publication of udi requirements along with the establishment of a global unique device identification database gudid is expected to have several positive impacts for health care providers medical device stakeholders and patients within the health care system. 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 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. 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.