HIDA Government Affairs Alert

October 8, 2013

HIDA Releases FAQ on Federal Unique Device Identification Final Rule

HIDA has created a UDI FAQ document for our members regarding the final rule for the implementation of the federal unique device identification (UDI) requirements released by the Food and Drug Administration (FDA) on September 24, 2013. This resource provides key takeaways that both distributor and manufacturer member companies should know.

Download HIDA's member resource:
UDI Final Rule FAQ
(Adobe PDF File)

HIDA is in the process of closely reviewing the draft guidance on the establishment of the Global Unique Device Identification Database (GUDID) that accompanied the release of the final rule. The FDA is accepting comments on the GUDID interim guidance through November 24, 2013. HIDA is working with its UDI work group to determine whether formal comments are needed. More detailed information will be forthcoming regarding the GUDID interim guidance.

Please contact HIDA Government Affairs if you have any questions, HIDAGovAffairs@HIDA.org or 703-838-4432.