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During and After Review

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

Abstract

You have finally compiled all your data into the appropriate package and submitted it to the FDA. Now what? The FDA will begin their review. However, the journey is not over after the FDA completes their review. This chapter provides a summary of the review process indicating the time points when you should anticipate hearing from the FDA. After the review is finished, you will want to market, advertise and promote your device—there are rules to follow. You also have post-marketing requirements, including safety surveillance, periodic reports due to the FDA and tracking requirements. In addition to all of that, there is always the possibility that your device will need an update (new materials, updated user interface, etc.). In the unlikely event that something “bad” happens after marketing, we have provided information about device recalls, corrections and removals.

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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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