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Related Experiment Videos

Regulatory issues in tumor marker development.

Steven Gutman1

  • 1Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.

Seminars in Oncology
|June 14, 2002
PubMed
Summary
This summary is machine-generated.

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The Food and Drug Administration (FDA) regulates in vitro diagnostic devices (IVDs) and tumor markers. Oversight varies based on intended use and commercialization, balancing public health with market access.

Area of Science:

  • Medical Device Regulation
  • In Vitro Diagnostics
  • Oncology Biomarkers

Background:

  • The Food and Drug Administration (FDA) has regulated medical devices, including in vitro diagnostic devices (IVDs), since 1976.
  • Regulatory controls encompass both premarket and postmarket surveillance.
  • Tumor marker oversight is influenced by intended use and commercialization methods.

Purpose of the Study:

  • To outline the regulatory framework for tumor markers in the United States.
  • To explain how the FDA categorizes and reviews these diagnostic tools.
  • To highlight the balance between regulatory oversight and public health promotion.

Main Methods:

  • Review of the FDA's regulatory pathways for medical devices.
  • Analysis of classification criteria for in vitro diagnostic devices (IVDs) and tumor markers.

Related Experiment Videos

  • Examination of premarket review processes, including 510(k) and Premarket Approval (PMA) applications.

    • Main Results:

    • Oversight of tumor markers is determined by their intended use and how they are marketed (test kits/systems vs. laboratory services).
    • Tumor markers may undergo 510(k) or Premarket Approval (PMA) review, or be exempt.
    • The FDA employs a balanced approach to regulation, prioritizing public health.

    Conclusions:

    • The FDA's regulatory strategy for tumor markers is adaptable, considering test utility and market presentation.
    • Regulatory pathways ensure appropriate scrutiny while facilitating access to important diagnostic tools.
    • The FDA's mission focuses on safeguarding public health through effective medical device oversight.