In vitro diagnostics (IVDs) have a vital role in improving patient outcome and public health surveillance. IVDs are used to detect diseases, monitor health conditions, guide treatment decisions, detect diseases early on, and support precision medicine. Hence, IVDs...
The US FDA 510(k) approval process authorizes the marketing of IVDs in the US. Through this process the Food and Drug Administration (FDA) evaluates device safety and effectiveness before releasing it in the market. Hence, compliance with US FDA...
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