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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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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 • Analytical sensitivity • Limits of detection
Clinical Performance • Clinical sensitivity • Clinical specificity • Likelihood ratios • Per cent agreement
Clinical Utility • Impact resulting from test use
Standardized Models • Literature • Guidances • Standards
Published Roadmaps • STARD initiative • REMARK initiative
Bad News • Complex science • Lack of material and method standards • Sources of data bias • Informed consent
Good News • Refined regulatory tool box • Pre-IDEs • Expedited reviews • De novo classifications • Real time reviews
Good News • Least burdensome • User fees • Seasoned program
Two Tests for Metabolic Enzymes • CYP 450 • UGT-1A1
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
FDA Mission • Promote public health • Protect public health • Tension
Good Science • Focused review • Relevant questions