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General Overview of Development Process

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

Abstract

You have an idea for a device that will make life easier for patients, physicians, caregivers, or all of the above. That’s great! But now what? Device regulation is a hot topic in industry right now. Because there have been amazing advances in medical device technology, medical device regulation has had to evolve to encompass these complexities. In this changing landscape, it is difficult to know what is required and what next steps you should take. This chapter provides a history of device regulation, but more importantly, it provides information to help you determine what type of device you have; a general development plan; and basic information on the FDA’s classification and regulatory pathways for clearance/approval/grant.

References

  1. 1.
    Ellis, Harold, A History of Surgery, p. 47, Cambridge University Press (2001).Google Scholar
  2. 2.
    Geison G.L., Pasteur’s work on rabies: Reexamining the ethical issues, 8 (2): 26–33, Hastings Center Report (1978).CrossRefGoogle Scholar
  3. 3.
    Nitske, RW., The life of W. C. Röntgen, Discoverer of the X-Ray, University of Arizona Press, (1971).Google Scholar
  4. 4.
    Ridings J.E., The thalidomide disaster, lessons from the past, 947:575–86, Methods Mol Biol., (2013).Google Scholar
  5. 5.
    21 U.S.C. § 321(h).Google Scholar
  6. 6.
    21 C.F.R. § 820.3(c).Google Scholar
  7. 7.
    FDA’s guidance for Industry and FDA Staff: Medical Device Accessories Describing Accessories and Classification Pathways (2017).Google Scholar
  8. 8.
    21 U.S.C. § 321(g).Google Scholar
  9. 9.
    42 U.S.C. § 262(i).Google Scholar
  10. 10.
    21 C.F.R. § 809.3.Google Scholar
  11. 11.
    21 C.F.R. § 880.6310.Google Scholar
  12. 12.
    Greenstone G., The history of bloodletting, page(s) 12–14 BCMJ, Vol. 52, No. 1, (2010).Google Scholar
  13. 13.
    21 C.F.R. § 820.3(f).Google Scholar
  14. 14.
    Money AG, Barnett J, Kuljis J, Craven MP, Martin JL, Young T., The role of the user within the medical device design and development process: medical device manufacturers’ perspectives, 2011, 11:15, BMC Medical Informatics and Decision Making (2011).Google Scholar
  15. 15.
    FD&C Act, section 513.Google Scholar
  16. 16.
    21 C.F.R. § 812.3.Google Scholar
  17. 17.
    FD&C Act, section 513(f)(6).Google Scholar
  18. 18.
    21 C.F.R. § 820.Google Scholar
  19. 19.
    21 C.F.R. § 801.Google Scholar
  20. 20.
    21 C.F.R. § 809.Google Scholar
  21. 21.
    21 C.F.R. § 807, Subpart E.Google Scholar
  22. 22.
    21 C.F.R. § 814.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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