Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices

  • Selma A. Kunitz
  • Michele Gargano
  • Rene Kozloff


Deficiencies in recent medical device applications to the US Food and Drug Administration (FDA) have resulted in efforts to provide device manufacturers with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness. 1 Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clinical trial methods include a statement of a hypothesis, definition of a target population group, identification of patient and intervention characteristics (independent variables), and well-defined objective outcome measures (dependent variables or endpoints). Outcome measures, then, are a key component in the materials that the FDA uses to review and assess the safety and effectiveness of new devices.


Medical Device Spinal Cord Stimulation Health Status Measure Noninvasive Positive Pressure Ventilation Sickness Impact Profile 
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Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Selma A. Kunitz
  • Michele Gargano
  • Rene Kozloff

There are no affiliations available

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