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Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said. Read More
The Indian government is developing a medical device postmarket surveillance system, following a series of high-profile incidents in which faulty products harmed patients. Read More