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FDA Regulatory Pathways and Technical Considerations for the 3D Printing of Medical Models and Devices

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Notes

  1. 1.

    “Sponsor” is the term FDA uses for any person, company, or institution that sends a submission to the FDA.

  2. 2.

    The CDRH Organizational chart is available on the FDA website.

  3. 3.

    Contact DICE by email: DICE@fda.hhs.gov or by phone at 1 (800) 638-2041 or (301) 796-7100.

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Acknowledgments

We would like to thank Matthew Di Prima, Jennifer Kelly, David Hwang, and Laura Ricles of the CDRH Additive Manufacturing Working Group for their help in compiling this information and their continuing efforts in 3D printing regulation, research, and public education.

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Correspondence to James C. Coburn M.S., C.P.H. .

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© 2017 Springer International Publishing AG

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Coburn, J.C., Grant, G.T. (2017). FDA Regulatory Pathways and Technical Considerations for the 3D Printing of Medical Models and Devices. In: Rybicki, F., Grant, G. (eds) 3D Printing in Medicine. Springer, Cham. https://doi.org/10.1007/978-3-319-61924-8_10

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  • DOI: https://doi.org/10.1007/978-3-319-61924-8_10

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-61922-4

  • Online ISBN: 978-3-319-61924-8

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