A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.

Journal Article (Journal Article)

Commercialization has been slow since the FDA approved a medical device containing nanomaterials in 1980. In 2017, the FDA released draft guidance to accelerate approval. We highlight here that geographical and structural separation of researchers, manufacturers, and clinical servicers may slow commercialization more than FDA approval.

Full Text

Duke Authors

Cited Authors

  • Jones, A-AD; Mi, G; Webster, TJ

Published Date

  • February 2019

Published In

Volume / Issue

  • 37 / 2

Start / End Page

  • 117 - 120

PubMed ID

  • 30075863

Electronic International Standard Serial Number (EISSN)

  • 1879-3096

International Standard Serial Number (ISSN)

  • 0167-7799

Digital Object Identifier (DOI)

  • 10.1016/j.tibtech.2018.06.003


  • eng