Saturday, August 9, 2014

Update VIII - UDI update

Previous blog entries referencing UDI:

'FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Late' updates as follows: "... FDA is out with its final guidance on the GUDID, reflecting an extremely unusual approach. While most final guidance documents make changes to the original draft, FDA said many of the changes that it plans to make to the document will instead come in future revisions. "We plan to finalize this section separately," FDA writes a total of 14 times in the latest guidance document. Why the change? "In order to provide labelers access to the latest information as soon as it is available, and address sections that received the most comments and questions, sections of this document are finalized; sections still in draft state are noted and will be finalized at a later time," FDA explained. "A future document" will address those now-empty sections, FDA confirmed in its Federal Register posting on the guidance..."

'Justifying Value from UDI: A Provider's Review of Pilot Results' gives a nice overview of the expected benefits that will (eventually) be derived from the adoption of the UDI...


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