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Tips for Avoiding and Preventing Regulatory Problems

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

Abstract

For medical device companies that are required to comply with regulatory requirements, making a mistake can be costly. There is immense value in being proactive and cautious by looking for potential pitfalls and taking steps to avoid or mitigate regulatory issues before they can become regulatory problems. Keeping organized, up-to-date and well-documented are all good practices for achieving and maintaining compliance. Further, being prepared for FDA inspections by conducting periodic internal reviews and audits will go a long way toward reducing a company’s risk of being noncompliant. Remember that changes are inevitable in the medical device industry, but stay flexible—plans will change, official guidances will be updated, and regulations and laws will be revised. Taking action immediately to address changes and to address any other noncompliance issues will be the best course of action for a medical device company to avoid and prevent regulatory problems.

Reference

  1. 1.
    FDA Guide to Inspections of Qualify System, Aug. 1999, available online at https://www.fda.gov/downloads/ICECI/Inspections/InspectionGuides/UCM085938.pdf (accessed Aug. 21, 2018).

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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