Regulatory Perspectives for 3D Printing in Hospitals

Andy Christensen, Nicole Wake

Research output: Chapter in Book/Report/Conference proceedingChapter

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 languageEnglish (US)
Title of host publication3D Printing for the Radiologist
PublisherElsevier
Pages109-116
Number of pages8
ISBN (Electronic)9780323775731
DOIs
StatePublished - Jan 1 2021

Keywords

  • FDA
  • Liability
  • Point of care
  • Practice of medicine
  • Regulation

ASJC Scopus subject areas

  • Medicine(all)

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