We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A Swedish court has put temporary brakes on an order from the country’s Medical Products Agency that would require Medtronic to halt sales and recall its MiniMed 640G insulin pump. The stay will remain in place as Medtronic appeals the regulator’s actions before another court. Read More
The FDA and Centers for Disease Control and Prevention have advised healthcare facilities to strictly adhere to manufacturers’ instructions for use for reprocessing, as reports of improperly cleaned instruments continue to surface. Read More
Medical devicemakers soon could have a new way to measure quality, thanks to a program created jointly by the FDA and Xavier Health and recently adopted by the Medical Device Innovation Consortium. Read More
To reduce dosing errors that have resulted in deaths and patient adverse events, the FDA is providing manufacturers with labeling and safety testing recommendations for medical devices and combination products containing the blood thinner heparin. Read More
The FDA has warned AG Industries on medical device reporting failures related to a complaint of a mini-nebulizer shocking a child and other good manufacturing practice violations. Read More
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