An Intro to Medical Device Clinical Studies

Why are clinical studies necessary?

Medical device clinical studies provide evidence for a PMA submission. Under 21 CFR 860.7, the FDA relies only on “valid scientific evidence” to determine whether there is reasonable assurance that a device is safe and effective. Valid scientific evidence can originate from a variety of sources, including well-controlled studies. Even though there are options other than clinical studies to serve as the evidence for a PMA, 21 CFR 860.7(e)(2) emphasizes the use of well-controlled studies more than any other type of evidence.


What are the stages of medical device clinical studies?

  1. Exploratory Stage – first-in-human and feasibility studies, iterative learning, & product development (this stage helps better understand how the device may perform, its intended use, and how to select an appropriate pivotal study design)
  2. Pivotal Stage – definitive study to support the safety and effectiveness evaluation of the medical device for its intended use
  3. Postmarket Stage – includes studies intended to better understand the long-term effectiveness and safety of the device, including rare adverse events


Designing a medical device clinical study:

To design a medical device clinical study, one must consider: types of device studies, bias and variance, study objectives, subject selection, stratification, site selection, and comparative study designs. Some points to keep in mind in the key areas:

  • Types of Device Studies: clinical outcome studies are typically used for therapeutic and aesthetic devices (as well as some diagnostic devices), while diagnostic clinical performance studies are typically used for diagnostic devices
    • Clinical Outcome Studies: it is preferred that these studies be double-masked, randomized, and controlled. If masking cannot occur, bias should be addressed through controls
    • Diagnostic Clinical Performance Studies: It is preferred that these studies be masked to the third party evaluator but unmasked to the investigator.
  • Bias and Variance: an objective of a clinical study is to eliminate or reduce the bias; and, variance can be reduced by either a more efficient design or by a larger sample size

See all of the FDA’s thoughts on “Design Considerations for Pivotal Clinical Investigations for Medical Devices” here: Pivotal Stakeholder Presentation. They ended this presentation by noting that device studies “allow for a broad range of designs,” and they encourage companies to meet with the FDA for a pre-sub or IDE meeting to ask questions about medical device clinical study design.


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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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