UDI Introduction Dennis Black Director, e-Business BD In the following eleven slides, Dennis Black does a masterful job of explaining the many facets of UDI 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
UDI Requirements – Overview • The following is a high level overview of the FDA UDI Regulation. • You will not be an expert on UDI after this review and should review the Federal Register for a complete review of the regulation and consult your legal counsel. 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
What is the FDA UDI? Appearing in two forms* : Easily readable plain-text , and Automatic identification and data capture or AIDC technology Composed of two parts : Device Identifier or DI - mandatory, fixed, identifies the labeler and the specific version or model of a device; and Production Identifier(s) or PI – conditional, variable identifies one or more of the following when included on the label of a device: lot or batch number serial number expiration date date manufactured for an HCT/P (Human Cell, Tissue or Cellular or Tissue-Based Product) regulated as a device, the International Council for Commonality in Blood Banking Automation (ICCBBA). For all exceptions refer to UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
PI & DI: Using GTINs PI Production Information (Lot, Expiry, etc.) DI GTIN (Global Trade Item Number) Uniquely identifies the product. (This label is intended to depict GS1 standards. It is not yet compliant with UDI regulations.) 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
FDA UDI Rule Overview • Label with AIDC (barcode) • UDI=Device Identifier(DI)+Production Identifier(PI) MARK • UDI=GTIN + Standardized Production Data • Label plain-text ISO format date YYYY-MM-DD • Publish UDI plus required data attributes to the Global UDI Data Base (GUDID) SUBMIT • GDSN is one mechanism to publish that data once to both the FDA and customers • Year 1 (2014 ): Class III and devices licensed under PHS Act • Year 2 (2015): Class II/I implants and life-supporting/sustaining COMPLY • Year 3 (2016): Remainder of Class II • Year 5 (2018): Class I • For Direct Marking- Compliance dates are extended by 2 years except for FDASIA implants and life-supporting/sustaining UDI Final Rule Sept 24, 2013 GS1 US website: www.gs1us.org/hcudi FDA UDI Website: www.fda.gov/gov and click on “UDI Help Desk” 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
Issuing Agencies • The UDI will be created and maintained by device labelers based on global standards managed by FDA- accredited Issuing Agencies. • Issuing Agencies are: • GS1 • HIBC • ICCBBA UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
Labeler Definition “Labeler means: (1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and (2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition of the name of, and contact information for, a person who distributes the device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.” 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
UDI Date Format YYYY-MM-DD • Dates on medical device labels for the user o Must conform to a standard format consistent with international standards as year-month-day (for example, 2013- 09-30). In the event of an expiration in particular month, the labeler may choose the last day of the month for the date field. • Implementation Timeline - By UDI compliance date; if not – year 5 UDI Final Rule www.fda.gov/udi 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
General Exemptions Key Points: • FDA listened to stakeholders in creating exemptions. • FDA has not yet posted the exemptions that have granted post-UDI rule. • Some general exemptions are complicated and will require additional discussion for a better understanding. Source: Jay Crowley, “Not IF – but HOW… FDA’s Unique Device Identification (UDI) System –The Final Regulation.” September 23, 2013 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
FDA Global UDI Database (GUDID) • Repository of key device information. • Contains ONLY the DI, which serves as the primary key to obtain device information in the database and on the label. It also flags which PI attribute(s) are on the label. • The data elements described in the UDI Final Rule are included in the GUDID, consistent with their label plus data used to develop and maintain the GUDID, as well integrate with internal FDA systems. • Will be available to the public via the internet. UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
Example of Elements from GUDID Presented by E Fields, FDA at GS1 Connect 6-11-2014 2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago
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