by Foster Sayers
At 8:45 this morning the FDA pre-published the long anticipated final rule on Unique Device Identification.
Jay Crowley, the architect of the Global Unique Device Identification Database and leader of the UDI initiative made the announcement at the UDI conference in Baltimore to much applause.
The final rule will allow many organizations to move forward with their UDI projects with the certainty needed in order to ensure their efforts will lead to compliance.
As of now, the rule is available in PDF format only. Crowley announced at the conference that he expected the publication would appear in it's official final format on the Federal Register's website by Tuesday, September 24.
In my next blog post I will touch on some of the key differences between the proposed rule and the final rule published this morning.
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