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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