News In Brief
This article was originally published in The Silver Sheet
CDRH to publish final version of its national device post-market strategy by March; new UDI guidance coming; and more.
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A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.
The Swiss biotech's focal-onset seizure therapy, which is licensed from South Korea's SK and is already approved in the US, could have potential in indications beyond epilepsy, Arvelle's CEO tells Scrip.
Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.