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 In 2017, the FDA released draft guidance to accelerate approval.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