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- Title
Regulating 3D-printed medical products.
- Authors
Ricles, Laura M.; Coburn, James C.; Di Prima, Matthew; Oh, Steven S.
- Abstract
There are a number of key considerations in the U.S. regulatory landscape regarding approval of 3D-printed medical devices and biologics. Additive manufacturing [also known as three-dimensional (3D) printing] is the layer-wise deposition of material to produce a 3D object. This rapidly emerging technology has the potential to produce new medical products with unprecedented structural and functional designs. Here, we describe the U.S. regulatory landscape of additive manufactured (3D-printed) medical devices and biologics and highlight key challenges and considerations.
- Subjects
MEDICAL equipment; BIOLOGICALS; UNITED States. Food &; Drug Administration; MEDICAL supplies; REGENERATIVE medicine; TISSUE engineering
- Publication
Science Translational Medicine, 2018, Vol 10, Issue 461, p1
- ISSN
1946-6234
- Publication type
Article
- DOI
10.1126/scitranslmed.aan6521