Implementation of FDASIA: Unique Device Identifiers (UDI)

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Presentation transcript:

Implementation of FDASIA: Unique Device Identifiers (UDI) Statements by Sarah Sorscher, J.D., M.P.H Researcher, Public Citizen’s Health Research Group Tuesday, October 28, 2014 1

FDASIA ‘‘Not later than December 31, 2012, the Secretary shall issue proposed [UDI regulations]’’ “The Secretary . . . shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized . . .” Thursday, August 01, 2019

“Finished Device” Loophole (a) “The following types of devices are excepted. . . A finished device manufactured and labeled prior to the compliance date established by FDA.” codified as § 801.30 Thursday, August 01, 2019

Excessive Delay Congress requires UDIs under the Food and Drug Administration Amendments Act: 2007 Final implementation by the FDA: 2021 Total delay: 14 years Thursday, August 01, 2019

Direct Mark Requirement for Implanted Devices Thursday, August 01, 2019

Feasibility Blood vessel stent pacemakers Thursday, August 01, 2019

Usefulness Difficult to check once implanted, but Many problems require removal Already incorporated into health records, but medical institutions are slow to adapt doctors and nurses forget codes are mistranscribed patients move files are lost Thursday, August 01, 2019