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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
Devicemakers preparing for an FDA inspection should take steps to avoid some of the most common mistakes, such as lapses in complaint-handling procedures, David Lim, president and CEO of www.RegulatoryDoctor.com, said during a recent FDAnews webinar. Read More
Wright Medical’s Augment Bone Graft is once more on the road to FDA approval, following the agency’s agreement to accept a further PMA amendment on the product. Read More
The EU Parliament Wednesday advanced major data privacy legislation, but made revisions to the proposal that removed two provisions that industry had said would cripple clinical research efforts. Read More
Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures fall short of expectations. Read More