1. 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

2. 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

3. “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 §
Thursday, August 01, 2019

4. 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

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

6. Feasibility
Blood vessel stent
pacemakers
Thursday, August 01, 2019

7. 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