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Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular Devices

Registry-based IDEs in a Mature Device Space: An FDA Division of Cardiovascular Devices Perspective. Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health. 1.

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Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular Devices

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  1. Registry-based IDEs in a Mature Device Space: An FDA Division of CardiovascularDevices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health 1

  2. “…a reasonable assurance of safety and effectiveness” Safety: …probable benefits … outweigh the probable risks. Effectiveness: …in a significant portion of the target population, the use of the device for its intended uses and conditions of use, will provide clinically significant results. 2

  3. Essential Clinical Trial Elements • Objective, meaningful study endpoints • Appropriate inclusion/exclusion criteria • Appropriate control group (standard of care) • Minimize bias (with blinding if possible) • Minimize missing data • Statistical analysis plan • Prespecified study hypotheses • Sample size justification based on best estimates of event rates • Control of type I error (rule out chance)

  4. “Quality by Design” • General Principal: Enable meaningful benefit/ risk determination • Were the right patients enrolled (e.g., representative of intended use and consecutive?) • Are the CRF, definitions and protocol mandated follow-up schedule adequate? • Was the statistical comparison model (e.g., propensity score) appropriately developed in a prospective fashion? Can all patient data be independently reviewed by FDA? • Were key outcomes measured objectively in an unbiased manner? What degree of independent monitoring and review is necessary to ensure that this is the case? 4

  5. “Quality by Design” • General Principal: Enable meaningful benefit/risk determination • Does the trial have adequate power to measure clinically meaningful differences in a relevant population? If uncertain, has a sample size reestimation plan been prospectively developed? 5

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