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The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
Health product safety legislation introduced by Canada’s conservative government would require devicemakers to revise product labels to reflect new risk information, including updates on pediatric warnings, and conduct further tests when issues arise around at-risk populations. Read More
A proposed policy that would allow hospitals to set their own maintenance schedules for medical equipment could pose a significant risk to users of imaging and radiological devices, a coalition of medical societies says. Read More
A bill to regulate medical apps according to risk continues to spark debate, with supporters saying it is needed to protect innovation and detractors saying it is premature. Read More
Industry can expect an international effort to revise and update software device standards over the next few years, CDRH Director Jeffrey Shuren says. Read More
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
A group of patients is asking for sanctions against Johnson & Johnson’s Ethicon unit following allegations the company destroyed thousands of documents related to ongoing pelvic mesh trials. Read More