FDA Issues New Draft Guidance On Testing Medical Devices For Use In MRIs
The FDA has issued a draft guidance on how to determine what medical devices can enter an MRI machine safely.…
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The FDA has issued a draft guidance on how to determine what medical devices can enter an MRI machine safely.…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The FDA has issued a new draft guidance on how manufacturers should test devices made with nitinol, a metal alloy suspected of potentially causing allergic reactions in humans.…
Cybersecurity experts warn that old software used in medical equipment makes them vulnerable to hacking.…
The FDA is considering changes to its highly criticized 510(k) medical device approval program.…
A worldwide investigation raises concerns about the state of medical devices, how they are approved, and what happens when they are deemed to be unsafe.…
The FDA will hold a meeting next month to address the development of pediatric medical devices, which experts say has fallen behind the development of devices for adults.…
The FDA has announced new plans to speed up the approval of new medical devices, raising some concerns about patient safety.…
The FDA has published a list of more than 1,000 medical devices that are now exempt from premarket approval requirements.…