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Devicemakers in China can expect surprise inspections from that country’s Food and Drug Administration starting Sept. 1, according to recently released guidance. Read More
The European Medicines Agency is seeking information on an implant sold by a Medtronic unit after inspectors determined that a U.S.-based supplier of an active substance for the product had deviated from good manufacturing practices. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers. Read More
To reduce possible burn injuries, the FDA is recommending that manufacturers of magnetic resonance-conditional devices assess radiofrequency-induced heating in MR environments. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More
Inadequate investigations and corrective and preventive actions have been one of the top reasons for 483 observations since 1997, says James Vesper, president of LearningPlus. A 30-year veteran in the lifesciences business, Vesper talked with FDAnews about how to develop a successful CAPA program to uncover root causes of quality failures.Read More
The FDA is clarifying language related to the direct marking of medical devices for unique device identification purposes, including the definition of reprocessing. Read More