Medical centre recalls potentially infected body parts
نویسندگان
چکیده
منابع مشابه
Medical device recalls: get it right the first time: Comment on "Medical device recalls and the FDA approval process".
BACKGROUND Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices th...
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ژورنال
عنوان ژورنال: BMJ
سال: 2002
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.325.7360.356/b