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A Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials
- Jones, A-Andrew D., Mi, Gujie, Webster, Thomas J.
- Trends in biotechnology 2019 v.37 no.2 pp. 117-120
- commercialization, medical equipment, nanomaterials
- 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 In 2017, the FDA released draft guidance to accelerate approval.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.