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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 on a recent FDAnews webinar. 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 for devices fall short of expectations. Read More
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