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Australia’s TGA has issued hazard alerts for Microport Orthopedics metal-on-metal (MoM) hip implant components and Mathys Orthopaedics balanSys unicompartmental convex polyethylene inlays. Read More
The UK’s Medicines and Healthcare products Regulatory Agency released urgent field safety notices for a range of medical devices, including Zimmer Biomet’s patello-femoral joint milling handpiece, Avance and Amingo anaesthetic machines and monitors, and Fujifilm’s flexible duodenoscope. Read More
Australia’s TGA has issued a warning and halted a clinical study of St. Jude Medical’s Nanostim leadless cardiac pacemakers due to battery malfunctions. Read More
Circle Prime Manufacturing has received a Form 483 after an FDA inspection revealed inadequate records, complaint procedures and a failure to describe its vendor rating criteria. Read More
A Colorado device maker has received a Form 483 after investigators witnessed supplier observations and quality system issues. In total six observations were listed. Read More
Final FDA guidance updating device reporting requirements clarifies the obligations of contract manufacturers and makes other welcome changes to the March 2013 draft version. Read More
The FDA’s new online tool for reporting regulatory misconduct could subject industry to questionable allegations that disrupt business activities while producing little useful information for the agency, Hyman, Phelps, & McNamara attorney Jennifer Thomas said. Read More