Regulating 3D-printed medical products.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 30282697.
- Also identified by DOI 10.1126/scitranslmed.aan6521.
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Abstract
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.
Medical subject headings
- Equipment and Supplies
- Printing, Three-Dimensional
- Social Control, Formal