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A new proposed bill, the Safety of Untested and New Devices (SOUND) Act, was introduced by Representative Edward Markey at a press conference last month. The bill would allow the Food and Drug Administration
to require medical device manufacturers seeking approval for new
devices based on older devices that have safety issues to provide
documentation proving that the new product¿¿¿s design has fixed potential
...
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The Food and Drug Administration has issued a recall of several types of Automated External Defibrillators (AED)
because certain models contain a component that may fail unexpectedly
due to a defect. If the defective component failed during a rescue
attempt, the AED may not deliver defibrillation therapy and could cause
serious health consequences, including death.
AEDs are equipped with a self-test... Read More
