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