For nearly two years after learning of non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) impacting its hemodialysis machines, Fresenius Medical Care failed to take appropriate action, according to a December warning letter from the Food and Drug Administration.
FDA Rebukes Fresenius For Dragging Its Feet Over Toxins Risk
The US FDA issued a stern warning to Fresenius Medical Care over its slow approach to corrective actions over potentially harmful toxins emitted from its hemodialysis machines and accessories.

More from Regulation
More from Policy & Regulation
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.