FDA details changes to medical device review groups

December 20, 2012 by MassDevice staff

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)

News Well, 510(k), Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance

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