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CDRH – Regulation of Diagnostic Devices

Steven Gutman, M.D. CDRH – Regulation of Diagnostic Devices. Medical Device Amendments of 1976. General controls Registration and listing Good manufacturing practices Medical device reporting. Premarket Review. 510(k) PMAs. Analytical Performance. Accuracy Precision

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CDRH – Regulation of Diagnostic Devices

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  1. Steven Gutman, M.D. CDRH – Regulation of Diagnostic Devices

  2. Medical Device Amendments of 1976 • General controls • Registration and listing • Good manufacturing practices • Medical device reporting

  3. Premarket Review • 510(k) • PMAs

  4. Analytical Performance • Accuracy • Precision • Analytical sensitivity • Limits of detection

  5. Clinical Performance • Clinical sensitivity • Clinical specificity • Likelihood ratios • Per cent agreement

  6. Clinical Utility • Impact resulting from test use

  7. Standardized Models • Literature • Guidances • Standards

  8. Published Roadmaps • STARD initiative • REMARK initiative

  9. Bad News • Complex science • Lack of material and method standards • Sources of data bias • Informed consent

  10. Good News • Refined regulatory tool box • Pre-IDEs • Expedited reviews • De novo classifications • Real time reviews

  11. Good News • Least burdensome • User fees • Seasoned program

  12. Two Tests for Metabolic Enzymes • CYP 450 • UGT-1A1

  13. Common Approach • De novo classification • Analytical data – bi-directional sequencing as truth; extensive precision studies; impressive accuracy • Clinical literature – variable; threshold problem • Careful labeling -- transparent

  14. FDA Mission • Promote public health • Protect public health • Tension

  15. Good Science • Focused review • Relevant questions

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