Office of In Vitro Diagnostic Device Evaluation and Safety

The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regulates all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs). The Office was formed November 17, 2002, in order to consolidate all regulatory activities for IVDs. OIVD has a dual charge to foster the rapid transfer of new IVDs into the marketplace while preventing marketing of unsafe or ineffective devices. To accomplish this OIVD combines the functions of all the offices within CDRH into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs). OIVD carries out this Total Product Life Cycle approach by combining the pre-market review responsibilities of the Office of Device Evaluation (ODE), the enforcement responsibilities of the Office of Compliance (OC), and the post-market surveillance responsibilities of the Office of Surveillance and Biometrics (OSB). To support these regulatory responsibilities, OIVD maintains strong ties to the Office of Science and Engineering Laboratories (OSEL) for technical assistance, the Office of Communication, Education, and Radiation Programs (OCER) for communication and outreach assistance, and the Office of Management Operations (OMO) for program management assistance. The result is a multi-disciplinary and cross-linked organization which fosters efficient cradle-to-grave oversight of IVDs grounded in good science.

OIVD consists of a multidisciplinary group of scientists, medical technologists, policy analysts, engineers, pathologists, and clinicians who are collectively dedicated to promoting and protecting public health. Regardless of discipline, the staff strives to ensure that the medical and laboratory communities as well as other product users affected by their decisions have useful and safe products and they understand that information can foster better use of products. Consequently, the Office strives to ensure the work is transparent in order to allow all stakeholders to obtain the knowledge required to make informed decisions about the development, production, and use of IVDs. 

In supporting the laboratory community, OIVD administers the Clinical Laboratory Improvement Amendments (CLIA) '88 complexity program for the Centers for Medicare and Medicaid Services (CMS) by categorizing commercially marketed in vitro diagnostic tests by level of complexity (waived, moderate or high). The staff interacts with key stakeholders to ensure consistent and appropriate oversight of this important program.

Our unique and diverse expertise enhances the effectiveness and impact of CDRH programs. OIVD is composed of the Office of the Director and 3 Divisions:  Division of Chemistry and Toxicology Devices (DCTD), Division of Immunology and Hematology Devices (DIHD), and Division of Microbiology Devices (DMD).

General Product Areas Across the Divisions 

Division of Chemistry and Toxicology Devices (DCTD)

• General Chemistry Tests
• Specialized chemistry tests including neonatal biochemical screening tests, endocrine tests, and tests for women's health;
• Drug of abuse tests;
• Therapeutic drug monitoring tests;
• Minimally invasive and non-invasive tests.

Division of Immunology and Hematology Devices (DIHD)

• Hematology, pathology, flow cytometry, and coagulation tests;
• Tests for immunological disease;
• Tumor marker (cancer detection) tests;
• Genetic disorder (heritable somatic mutations) tests.

Division of Microbiology Devices (DMD)

• Detection of microorganisms (bacteria, fungi, mycobacteria, viruses) by chemical, immunological, and nucleic acid amplification methods;
• Biothreat agents;
• New and emerging infectious diseases.