A new study reveals the potential extent to which the medical device and pharmaceutical industries are influencing important health care decisions and how they can conflict with patient needs.
A proposed FDA guidance seeks to prevent medical devices from causing electromagnetic interference with other medical devices, which could create a safety risk for patients.
A new study warns the FDA may rely too heavily on adverse events to discover potentially life-threatening problems with approved medical devices.
Workers at a medical device warehouse in Georgia have filed a lawsuit against Sterigenics and ConMed, saying they were unwittingly exposed to high levels of a toxic, cancer-causing gas.
A class action lawsuit calls for Braun Medical to provide medical monitoring and compensation for those living around its Allentown facility, indicating that residents and workers were exposed to high…
The FDA is holding a public hearing on April 1 to discuss potential ways it can improve medical device safety warnings and recalls.
The FDA warns that the closure of a number of medical device sterilization facilities may lead to critical shortages and urges manufacturers to warn them of problems as early as…
Patient deaths may often go unreported or misclassified in FDA medical device reports, according to the findings of a new study.
The FDA will hold an advisory committee meeting in November focusing on the safety of metal used in medical implants.
The FDA has issued several new guidelines for mobile apps which will help determine which require federal oversight and which may not.