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FDA Meetings and Device Testing

  • Gerald B. Halt
  • John C. Donch
  • Amber R. Stiles
  • Lisa Jenkins VanLuvanee
  • Brandon R. Theiss
  • Dana L. Blue
Chapter

Abstract

Chapter  2 discussed device types and basic information on FDA classification and regulatory pathways. You still have questions—MANY questions. How do I test my device? Do I have to test it in animals first or can I go straight to human testing? Do I even need to test my device? These are all great questions and we provide some of the answers in this chapter. The first thing we cover in Chap.  3 is how to educate yourself using publicly available information and how to talk with the FDA. Meeting with the Agency doesn’t need to be scary! If done right, you will actually find it to be very helpful. The rest of this chapter is dedicated to discussing different testing that may be required in your submission. This includes an overview of nonclinical (animal), clinical (human), and human factor testing. The data collected will be used to support your submission.

References

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Gerald B. Halt
    • 1
  • John C. Donch
    • 2
  • Amber R. Stiles
    • 3
  • Lisa Jenkins VanLuvanee
    • 4
  • Brandon R. Theiss
    • 5
  • Dana L. Blue
    • 4
  1. 1.United PlazaVolpe and Koenig, P.C. United PlazaPhiladelphiaUSA
  2. 2.Volpe and Koenig, P.C.PhiladelphiaUSA
  3. 3.Miramar BeachUSA
  4. 4.Facet Life Sciences, Inc.WayneUSA
  5. 5.Volpe and Koenig, PCPhiladelphiaUSA

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