Posts Tagged ‘ 510(k) NHTSA ’

How to Post an Adverse Event with the FDA

Aug 30th, 2011 | By
Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient has a problem with
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