FDA details changes to medical device review groups

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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.

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)

  • 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 

The federal watchdog agency also provided updates on the Office of Communication, Education & Radiation programs, stating the group’s mission as one to "collaboratively support CDRH and the FDA in assuring the safety and effectiveness of medical devices and radiation-emitting electronic products" by fostering public discussion, educating industry and providing agency employees with information and training.

Finally, the FDA updated the online information regarding the CDRH Office of Device Evaluation, providing new details on the premarket notification program, premarket approval applications, PMA supplements and more.

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