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Devicemakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitation that Twitter imposes on messages, the FDA says. Read More
The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More
The FDA has provided devicemakers with nitty-gritty details on how to set up and use the Global Unique Device Identification Database, a key component of the universal tracking system set to take effect for Class III implantable devices on Sept. 24. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More