Mod6_pt5_InVitroDiagnostics

Mod6_pt5_InVitroDiagnostics - In Vitro Diagnostic Devices...

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1 In Vitro Diagnostic Devices Overview of Regulations PHAR 6010 David W. Mullis, Jr., Ph.D. RAC 2 Who Regulates IVDs? Center for Devices and Radiological Health (CDRH) Office of In Vitro Diagnostic Device Evaluation & Safety (OIVD) Division of Chemistry and Toxicology Devices Division of Immunology and Hematology Devices Division of Microbiology Devices Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) Division of Blood Applications (DBA) Note: DBA schedules all review-related meetings for OBRR Division of Hematology (DH) 3
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2 Regulatory Authority • FD&C Act Section 201(h)-Medical Device Premarket Controls Postmarket Regulations • Public Health Services Act, Section 351- Biologic Product • Clinical Laboratory Improvement Amendments (CLIA) of 1988 4 What is an IVD? • IVDs are medical devices • IVDs may be biologic products (351PHS Act) •I n V i
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Mod6_pt5_InVitroDiagnostics - In Vitro Diagnostic Devices...

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