“The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—‘‘(A) is or has been used in or on a patient; and ‘‘(B) is a class III device; or ‘‘(ii) a class II device that is implantable.”
All that says is that they will create a registry of medical devices so they know what device is put into which person so if that device has a safety recall they can contact that person.
AKA if you got in a car accident and they had to put in a titanium ankle joint and years later there is a safety recall, this would enable them to find you and call you because there is a registry.
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11-12-2012
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