FDA Gives Device Makers Few Ways Out Of Reporting Injuries

Law360, New York (July 8, 2013, 3:50 PM EDT) -- The U.S. Food and Drug Administration on Monday spelled out circumstances in which medical device manufacturers must disclose problems with their products, leaving little wiggle room to avoid reporting incidents of major patient harm.

In its draft guidance, the FDA said device companies must alert regulators to deaths and serious injuries not only when their products malfunction, but also when a health care practitioner misuses the equipment.

In that scenario, while the device might very well be completely safe, it is also possible that the mistake...
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