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Registration Certificate for in Vitro Testing for Laboratorio Clinico Sonia Sepulveda Pbadupws Nrc  Form

Registration Certificate for in Vitro Testing for Laboratorio Clinico Sonia Sepulveda Pbadupws Nrc Form

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the FDA is divided up into different organizations and the Center for device and radiological health CDRH is the one that regulates medical devices including IV DS within the CDRH the office of in vitro diagnostics and radiological health o ir is the specific department which regulates IV DS except those under the responsibility of the office of blood research and review Oh BRR see below unlike the rest of the CDRH the office of in vitro diagnostics and radiological health does everything in-house including premarket review and post market surveillance and it also makes complexity categorization and waiver determinations under the clinical laboratory Improvement Amendments CLIA of 1988 which will be discussed later in this course IV DS that are regulated by the Center for biologics Evaluation and Research Sieber include those for screening or confirmatory laboratory tests associated with blood banking operations as well as those intended for use in collecting processing storing and adm

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