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Medical Imaging and FDA Regulatory Pathway for Radiology devices

Author

Listed:
  • Sunil Aggarwal
  • Somya Aggarwal

    (Independent scholars, New York, USA)

Abstract

The medical imaging arena is fast developing and changing from the days of simple X-rays to advanced MRI imaging. Radiological imaging is very important in the targeted, clinical diagnosis and management of patients, may it be Ultrasound, CT scan or MRI and needs continuous evolution. Continuous evolving and developing medical imaging technologies need state- of -the art quality assurances and regulations as they are used on patients in every possible diagnosis. FDA’s Center for devices and radiological health (CDRH) is the regulatory body in US that is required to clear medical imaging therapeutic and diagnostic radiological devices intended to enter the market for sale.

Suggested Citation

  • Sunil Aggarwal & Somya Aggarwal, 2016. "Medical Imaging and FDA Regulatory Pathway for Radiology devices," Current Trends in Clinical & Medical Imaging, Juniper Publishers Inc., vol. 1(1), pages 1-2, October.
    • Handle: RePEc:adp:jctcmi:v:1:y:2016:i:1:p:1-2
    DOI: 10.19080/CTCMI.2016.01.555551
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