Bayesian Statistics at the FDA: The Pioneering Experience with Medical Devices. Greg Campbell, Ph.D. Director, Division of Biostatistics Center for Devices and Radiological Health Food and Drug Administration Florida State University Dept. of Statistics 50 th Anniv. April 17, 2009.
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Greg Campbell, Ph.D.
Director, Division of Biostatistics
Center for Devices and Radiological Health
Food and Drug Administration
Florida State University
Dept. of Statistics 50th Anniv.
April 17, 2009
Center for Drug Eval. & Research with Medical Devices
Center for Devices & Rad. Health
Food and Drug
Definition by exclusion: any medical item for use in humans that is not a drug nor a biological product
spinal fixation devices
artificial heartshearing aids
artificial skinsoftware, etc
home kit for AIDS diagnostic test kits
Example:Cordis’ Cypher™ Sirolimus-Eluting Coronary Stent
For the above, summaries of previous studies may not be sufficient to formulate prior; e.g., patient-level data are often necessary.