United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-07-10 article Part III Proposed Rules D09002ee1c7fcc27d D09002ee1c7fcc35d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use. 77 FR 40736 https://www.govinfo.gov/app/details/FR-2012-07-10/2012-16621 2012-16621 fr10jy12-37 RIN 0910-AG31 4160-01-P Docket No. FDA-2011-N-0090 https://www.govinfo.gov/app/details/FR-2012-07-10/2012-16621 https://www.govinfo.gov/content/pkg/FR-2012-07-10/html/2012-16621.htm https://www.govinfo.gov/content/pkg/FR-2012-07-10/pdf/2012-16621.pdf Administrative Practice and Procedure Labeling Medical Devices Reporting and Recordkeeping Requirements Imports Confidential Business Information Medical Research 43 p. 40736 40778 77 FR 40736 Title 21 Part 16 21 CFR Part 16 Title 21 Part 801 21 CFR Part 801 Title 21 Part 803 21 CFR Part 803 Title 21 Part 806 21 CFR Part 806 Title 21 Part 810 21 CFR Part 810 Title 21 Part 814 21 CFR Part 814 Title 21 Part 820 21 CFR Part 820 Title 21 Part 821 21 CFR Part 821 Title 21 Part 822 21 CFR Part 822 Title 21 Part 830 21 CFR Part 830 RIN 0910-AG31 Unique Device Identification System; Federal Register Vol. 77, Issue PRORULE 2012-16621 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-11-07 Docket No. FDA-2011-N-0090 4160-01-P 2012-16621 Proposed rule.

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.

Submit either electronic or written comments on the proposed rule by November 7, 2012. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 10, 2012, (see section V, the "Information Collection Requirements" section of this document). See section VII for the proposed effective date of a final rule based on this proposed rule. Jay Crowley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, 301-796-5995, email: cdrhudi@fda.hhs.gov. Administrative Practice and Procedure Labeling Medical Devices Reporting and Recordkeeping Requirements Imports Confidential Business Information Medical Research Unique Device Identification System , cdrhudi@fda.hhs.gov OIRA_submission@omb.eop.gov http://wiki.hl7.org/index.php?title=Medical_Product_Information_ http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htm http://www.fda.gov/udi http://www.gs1us.org/standards/barcodes http://www.hibcc.org/AUTOIDUPN/ANSI%20HIBC%202.3%20SLS%202009.pdf http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332 http://www.reginfo.gov/public/do/PRAMain http://www.regulations.gov www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html www.standardsinfo.net Vol. 77, no. 132 Office of the Federal Register, National Archives and Records Administration 2012-07-10 continuing daily deposited born digital 329 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-07-10 P0b002ee182a93c72 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10jy12 https://www.govinfo.gov/app/details/FR-2012-07-10 https://www.govinfo.gov/content/pkg/FR-2012-07-10/pdf/FR-2012-07-10.pdf https://www.govinfo.gov/content/pkg/FR-2012-07-10/xml/FR-2012-07-10.xml fdlp 40459 40778 DGPO 2012-07-10 2024-06-03 FR-2012-07-10 machine generated eng FR FR-2012-07-10 77 132