Wednesday, December 3, 2008

Nice Review of US FDA Medical Device Regulation

This is an excellent introduction to, and review of the FDA's Medical Device Regulations. This report, "Review of U.S. Medical Device Regulation," published in the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA). The report tackles the subject in the following sub-topics . . .

  1. Introduction
  2. Regulatory Definition of Medical Devices
  3. Risk-Based Device Classification
  4. Safety and Effectiveness Requirements
  5. Food and Drug Administration Programs/Regulatory Pathways
  6. Quality Systems Regulation (QSR)
  7. Regulation of Drug-Device Combinations (Combination Products)
  8. Guidance Documents Available to the Device Industry
  9. Conclusions

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