Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery.…
The FDA found a wide range of GMP and other violations during inspections of six devicemakers. Source: The GMP Letter
Two manufacturers of liquid-filled balloons for obesity treatment have revised their labeling to include warnings of the risks. Source: The GMP Letter
The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities.…
The FDA cut off imports from a Chinese manufacturer of hospital beds, stretchers and operating-room tables after an inspection discovered multiple violations of quality standards, the agency said in a…
A German sunlamp manufacturer failed to measure up to several quality standards in an inspection of its plant in Berlin, and the FDA moved to bar imports from the company…
A federal judge ruled St. Jude may not dismiss a patient’s allegations over manufacturing-defects and negligence related to the company’s implantable cardiac defibrillator in a case filed with the U.S.…
A recently introduced cybersecurity bill for medical devices is attracting some support — at least from the medical community. Source: The GMP Letter
The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall. Source: The GMP Letter
Six device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and other procedures. Source: The GMP Letter