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Successful Implementation of a Medical Device Company’s Regulatory Strategy

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

Abstract

Regulatory compliance is focused on bringing a safe and effective medical device product to market. Regulatory compliance involves more than merely submitting a 510(k) or PMA to the FDA for clearance or approval. Rather, regulatory compliance involves the thoughtful planning, development and implementation of a medical device regulatory strategy, which is the evaluation of the various pathways to market that are available for a medical device, and identification of how to go about accomplishing each one, while taking into considerations the benefits, risks, burdens and costs associated with each potential option. Regulatory strategy also involves anticipating potential problems and developing a plan to address, mitigate or avoid those problems. Each medical device product will have its own regulatory strategy, which is likely to evolve as the medical device product transitions through development to market. Regulatory strategy starts before an FDA submission is made and lasts well into commercialization of the medical device.

References

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    21 C.F.R. § 820.Google Scholar
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    21 C.F.R. § 820.30.Google Scholar
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    ISO 13485:2016.Google Scholar
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    21 C.F.R. § 820.181.Google Scholar
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    21 C.F.R. § 820.198.Google Scholar
  6. 6.
    ISO 13485:2016, section 8.2.2.Google Scholar

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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