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Some devicemakers preparing for the European Commission’s regulation on restricting hazardous substances (RoHS 2), which comes into effect in July, are feeling a financial squeeze from its requirements. Read More
When applying CLIA categorization of diagnostics, CDRH plans to alert sponsors to the categorization within two weeks of a positive marketing decision, the agency says. Read More
The FDA’s draft guidances for OTC and prescription point-of-care blood glucose tests create overly burdensome clinical trial requirements that may chill development of new products, stakeholders say. Read More