Regulatory Perspectives for 3D Printing in Hospitals

Andy Christensen; Nicole Wake

doi:10.1016/B978-0-323-77573-1.00015-4

Regulatory Perspectives for 3D Printing in Hospitals

Andy Christensen, Nicole Wake

Radiology

Research output: Chapter in Book/Report/Conference proceeding › Chapter

2 Scopus citations

Abstract

The United States (US) Food and Drug Administration (FDA) has overseen medical device marketing in the US since 1976. Although the FDA regulates the medical device industry which designs, manufactures, and sells medical devices to physicians and hospitals, the FDA does not typically regulate hospitals or individual physicians. This chapter will review medical device classifications according to the FDA and will discuss regulatory considerations for hospitals creating 3D printed medical devices at the point of care.

Original language	English (US)
Title of host publication	3D Printing for the Radiologist
Publisher	Elsevier
Pages	109-116
Number of pages	8
ISBN (Electronic)	9780323775731
DOIs	https://doi.org/10.1016/B978-0-323-77573-1.00015-4
State	Published - Jan 1 2021

Keywords

FDA
Liability
Point of care
Practice of medicine
Regulation

ASJC Scopus subject areas

Medicine(all)

Access to Document

10.1016/B978-0-323-77573-1.00015-4

Cite this

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AB - The United States (US) Food and Drug Administration (FDA) has overseen medical device marketing in the US since 1976. Although the FDA regulates the medical device industry which designs, manufactures, and sells medical devices to physicians and hospitals, the FDA does not typically regulate hospitals or individual physicians. This chapter will review medical device classifications according to the FDA and will discuss regulatory considerations for hospitals creating 3D printed medical devices at the point of care.

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KW - Point of care

KW - Practice of medicine

KW - Regulation

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ER -

Regulatory Perspectives for 3D Printing in Hospitals

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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