Us fda registration and medical device listings us fda citation 21 cfr 807 2016 the us fda is responsible for regulating firms who manufacture repackage relabel and or import medical devices sold in the united states. Device advice overview of regulations for medical devices premarket notifications 510k establishment registration device listing quality systems labeling and reporting requirements. Medical devices are subject to registration manufacturers must submit the registration application to the dcd if the registration application is approved the dcd issues an identification number and a registration certificate applicant foreign manufacturer via local representative local authorized representative. Regulatory alert fda amends regulations for medical device registration and listing requirements on august 2 2012 fda published a final rule amending regulations to meet statutory amendments to the device registration and listing provisions of the federal food drug and cosmetic act as amended by the. Overview of fdas device regulations introduction fdas center for devices and radiological health cdrh is responsible for regulating firms who manufacture repackage relabel and or import medical devices sold in the united states
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