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Device Versus Drug Clinical Trials: Similarities and Important Differences

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Success in Academic Surgery: Clinical Trials

Part of the book series: Success in Academic Surgery ((SIAS))

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Abstract

The regulatory requirements for investigational drugs and devices are complex, and the clinical investigator must have a working knowledge of these requirements as mandated by the Food and Drug Administration in order to effectively bring a product to market. Preclinical laboratory data must support an application in order to test the drug or device in humans. A clinical trial focused to gain approval then proceeds through defined phases of clinical testing. Data from the clinical investigations must be used in the various application documents required to legally market a new drug or device. The differences between the drug and device approval process include classifications based on risk, different application documents, and different checkpoints in the investigational and approval process.

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Author information

Authors and Affiliations

  1. Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA

    T. Clark Gamblin MD, MS & William S. Ragalie MD

Authors
  1. T. Clark Gamblin MD, MS
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  2. William S. Ragalie MD
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Corresponding author

Correspondence to T. Clark Gamblin MD, MS .

Editor information

Editors and Affiliations

  1. Department of Surgery, Johns Hopkins, Baltimore, USA

    Timothy M. Pawlik

  2. Department of Surgery,, Duke University School of Medicine,, Durham, North Carolina, USA

    Julie A. Sosa

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© 2014 Springer-Verlag London

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Gamblin, T.C., Ragalie, W.S. (2014). Device Versus Drug Clinical Trials: Similarities and Important Differences. In: Pawlik, T., Sosa, J. (eds) Success in Academic Surgery: Clinical Trials. Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-1-4471-4679-7_10

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  • DOI: https://doi.org/10.1007/978-1-4471-4679-7_10

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4678-0

  • Online ISBN: 978-1-4471-4679-7

  • eBook Packages: MedicineMedicine (R0)

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