Advertisement

Compiling and Submitting Your Device Application

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

Abstract

As mentioned in Chap.  3, all medical device Sponsors have an obligation to read and understand the regulations and guidances that apply to their product. Being a conscientious Sponsor, you read and followed all the “rules” and even chatted with the FDA routinely and applied their feedback. You have data … tons of data. Now what? The most exciting (and rigorous) part of your journey is about to begin—your submission. The first thing covered in this chapter is what data the FDA requires in your submission package. The type of data you include in your submission package is dependent on your device class/type and any special regulations for your device and its intended use. Next, labeling is discussed—what you can say and how to say it best so your intended users understand. Unfortunately, there are fees associated with submissions, and in order to keep you from being surprised, this chapter concludes with a section covering the financial side of your submission.

References

  1. 1.
    FDA Guidance, The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, available online at https://www.fda.gov/RegulatoryInformation/Guidances/ucm080187.htm (accessed Aug. 31, 2018).
  2. 2.
    Federal Register Notices, Vol. 78, No. 4, page 951, January 7, 2013, available online at https://www.gpo.gov/fdsys/pkg/FR-2013-01-07/pdf/2013-00003.pdf (accessed Aug. 31, 2018).
  3. 3.
    Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation, April 17, 2018, available online at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm604672.htm (accessed Aug. 31, 2018).
  4. 4.
    U.S. Registration No. 4,021,057. Owner: Terumo Corporation.Google Scholar
  5. 5.
    U.S. Registration No. 2,738,542. Owner: Angel Medical Systems, Inc.Google Scholar
  6. 6.
    FDA Types of FDA Enforcement Actions website, updated Nov. 6, 2017, available online at https://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm268127.htm (accessed Aug. 31, 2018).
  7. 7.
    U.S. FDA, FY 2018 MDUFA User Fees, available online at https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452519.htm.

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

Personalised recommendations