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

TitleA Status Report on FDA Approval of Medical Devices Containing Nanostructured Materials.
Publication TypeJournal Article
Year of Publication2019
AuthorsA-AD Jones, G Mi, and TJ Webster
JournalTrends in Biotechnology
Volume37
Start Page117
Issue2
Pagination117 - 120
Date Published02/2019
Abstract

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 In 2017, the FDA released draft guidance to accelerate approval.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

DOI10.1016/j.tibtech.2018.06.003
Short TitleTrends in Biotechnology