The draft guidance was issued to provide clarification on the UDI labeling requirements.
To download the draft guidance on Form and Content of the UDI click here.
To learn more about HIBCC as an FDA-accredited UDI issuing agency click here.
- 19 Feb 2019Medical Technology Association of Australia (MTAA) releases final UDI System Proposal
- 05 Feb 2019MedTech Europe releases document on the differences in UDI requirements for the US and EU
- 29 Nov 2018HIBCC designated by the Saudi-Arabian FDA as a UDI Issuing Agency in Draft Regulation
- 23 Oct 2018HIBCC met with European Commission and FDA in Silver Springs, MD on October 17th
- 16 Jul 2018Deactivation of iHIN Guest Accounts