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

Publication ,  Journal Article
Jones, A-AD; Mi, G; Webster, TJ
Published in: Trends in biotechnology
February 2019

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 In 2017, the FDA released draft guidance to accelerate approval.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.

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Published In

Trends in biotechnology

DOI

EISSN

1879-3096

ISSN

0167-7799

Publication Date

February 2019

Volume

37

Issue

2

Start / End Page

117 / 120

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Nanostructures
  • Equipment and Supplies
  • Device Approval
  • Biotechnology
  • 3206 Medical biotechnology
  • 3106 Industrial biotechnology
  • 3001 Agricultural biotechnology
  • 10 Technology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Jones, A.-A., Mi, G., & Webster, T. J. (2019). A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials. Trends in Biotechnology, 37(2), 117–120. https://doi.org/10.1016/j.tibtech.2018.06.003
Jones, A-Andrew D., Gujie Mi, and Thomas J. Webster. “A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.Trends in Biotechnology 37, no. 2 (February 2019): 117–20. https://doi.org/10.1016/j.tibtech.2018.06.003.
Jones A-AD, Mi G, Webster TJ. A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials. Trends in biotechnology. 2019 Feb;37(2):117–20.
Jones, A. Andrew D., et al. “A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.Trends in Biotechnology, vol. 37, no. 2, Feb. 2019, pp. 117–20. Epmc, doi:10.1016/j.tibtech.2018.06.003.
Jones A-AD, Mi G, Webster TJ. A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials. Trends in biotechnology. 2019 Feb;37(2):117–120.
Journal cover image

Published In

Trends in biotechnology

DOI

EISSN

1879-3096

ISSN

0167-7799

Publication Date

February 2019

Volume

37

Issue

2

Start / End Page

117 / 120

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Nanostructures
  • Equipment and Supplies
  • Device Approval
  • Biotechnology
  • 3206 Medical biotechnology
  • 3106 Industrial biotechnology
  • 3001 Agricultural biotechnology
  • 10 Technology