Fda Unique Device Identification Medical Devices

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Unique Device Identification System (UDI System) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the device....

Global Unique Device Identification Database (GUDID)

https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/global-unique-device-identification-database-gudid

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 …

Unique Device Identification: Direct Marking of Devices

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-direct-marking-devices

Under 21 CFR 801.45, " [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 …

AccessGUDID (for the public) | FDA

https://www.fda.gov/medical-devices/global-unique-device-identification-database-gudid/accessgudid-public

In collaboration with the National Library of Medicine, the FDA has created a portal, called AccessGUDID, to make device identification information in the GUDID available for...

AccessGUDID - Identify Your Medical Device

https://accessgudid.nlm.nih.gov/

The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to …

Benefits of a UDI System | FDA

https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/benefits-udi-system

When fully implemented, the Unique Device Identification System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems by: …

Unique Device Identification: Convenience Kits | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-convenience-kits

FDA’s unique device identification system includes unique device identifier (UDI) labeling (21 CFR 801.20) and data submission requirements (21 CFR 830.300). The unique …

eCFR :: 21 CFR Part 830 -- Unique Device Identification

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20. A UDI is …

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