divendres, 27 de juny del 2014

FDA finalizes unique device identifier rules




The FDA puts the finishing touches on its unique device identifier program guidance, issuing a final rule that encompasses labeling, the UDI database and initial submissions.





FDA finalizes unique device identifier rules

The FDA today released the final version of its guidance regarding the new unique device identifier program, a new mandate that requires certain medical devices to have coded labels that make them trackable via a national database.


U.S. regulators issued a finalized rule that encompasses prior guidances into a single document, providing the final rules on the global UDI database, advice for initial submissions and other elements of the program.




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