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|
|Number of pages||8|
|State||Published - Jan 1 2021|
- Point of care
- Practice of medicine
ASJC Scopus subject areas