The rule consists of two parts: unique device identifiers (or UDI codes) assigned by device makers to their devices, and a public database (called Global Unique Device Identification Database or GUDID) containing the UDI codes that will be managed by the FDA.
The FDA said medical device records will have to include the UDI code. The rule also establishes accreditation requirements for agencies that may operate systems for issuing UDI codes.
The FDA plans to phase in the UDI rule. All Class III devices must carry UDI labels within 1 year. Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply.
The new rule is effective 90 days after today's publication in the Federal Register.
- FDA's News Release on the new rule: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
- Final rule: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system
- Draft guidance on GUDID: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf
