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.
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.
News Well, Food & Drug Administration (FDA), Regulatory/Compliance, Universal Device Identifier (UDI)
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/URbeZs
Cap comentari:
Publica un comentari a l'entrada