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 possible.…
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.…
Georgia officials are investigating a potential toxic gas release from a Sterigenics plant near Atlanta following a number of lawsuits over similar problems in Illinois.…
Dozens of lawsuits against Sterigenics claims the medical device sterilization facility released highly carcinogenic chemicals into the air, causing numerous illnesses and cancer.…
The FDA has issued a draft guidance on how to determine what medical devices can enter an MRI machine safely.…
The FDA has released data on millions of unreleased medical device adverse event reports, announcing the end of a program which allowed some manufacturers to hide patient injuries and faulty device reports.…
A new report reveals the FDA has allowed manufacturers to hide more than a million reports of serious injury and medical device malfunction away from public view since 2016. …
The FDA has issued a new draft guidance on how manufacturers should test devices made with nitinol, a metal alloy suspected of potentially causing allergic reactions in humans.…
