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U.S. Department of Health and Human Services

About FDA

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Office of In Vitro Diagnostics and Radiological Health

The Office of In Vitro Diagnostics and Radiological Health (OIR):

  • regulates in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs);
  • regulates radiological medical devices;
  • regulates radiation-emitting non-medical products; and
  • implements the Mammography Quality Program authorized by the Federal Mammography Quality Standards Act of 1992.

Formerly called the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), OIR consolidates all regulatory activities for IVDs and radiological medical devices, along with electronic product radiation control responsibilities and leadership of the Mammography Quality Program. In order to foster innovation, assure that patients have access to safe, effective and high quality medical devices and prevent the marketing of unsafe or ineffective devices, OIR combines pre-market and post-market responsibilities into one multi-disciplinary office. In addition, OIR administers the federal law that supports the clinical laboratory community (the Clinical Laboratory Improvement Amendments—CLIA).

OIR Divisions and General Responsibilities

OIR is comprised of the Office of the Director (OD), which includes the Personalized Medicine (PM) staff, and six 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
Division of Radiological Health (DRH)
  • Diagnostic radiology devices (e.g. X-ray devices, magnetic resonance imaging systems, computed tomography systems, ultrasound systems, nuclear medicine devices, picture archiving and communications systems)
  • Radiation therapy devices (e.g. linear accelerators, brachytherapy systems)
  • Medical and non-medical electronic product radiation control (e.g. ultrasound products and devices, laser products and devices, and microwave products and devices)
Division of Mammography and Quality Standards (DMQS)
  • Implements the Mammography Quality Program authorized by the Federal Mammography Quality Standards Act of 1992
Division of Program Operations and Management (DPOM)
  • Provides scientific support, incorporating project management activities as well as shared oversight of all the necessary quality assurance and quality control mechanisms to ensure smooth running of premarket and postmarket operations
  • Provides administrative support, including oversight over program management functions (human resources, budget, travel, training, etc.) that enable management and staff to operate efficiently