FDA details changes to medical device review groups

December 20, 2012 by MassDevice staff

The FDA provides details on the breakdown for the new Office of In Vitro Diagnostics and Radiological Health, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.

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The FDA this week provided updates on the revamped Office of In Vitro Diagnostics & Radiological Health, formerly known as the Office of In Vitro Diagnostic Device Evaluation and Safety.

The Center for Devices & Radiological Health subsection will oversee in-home and laboratory diagnostic tests, radiological medical devices and radiation-emitting non-medical products, and will be responsible for implementing the Mammography Quality Program established federally in 1992.

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The FDA further broke down the various sections with the ORI, defining their duties as follows:

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)

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