A Status Report on FDA Approval of Medical Devices Containing Nanostructured Material

Academic publishing and manufacturing trends in devices containing nanostructured material.
Academic publishing and manufacturing trends in devices containing nanostructured material. FDA 510 (k) cleared products by 72 unique manufacturers, including those later acquired, where either the manufacturers or the product name contains “nano.” Research publications in the PubMed database from 1980 – 2017 containing “nanoparticle” and “implant” but not containing “drug delivery.” Compared to nano based drugs, from PubMed “nanoparticle” and “drug delivery” extends to 3171 by 2017 and product data from Weissig and others, limiting the data set to 2014.

Commercialization has been slow since the Food and Drug Administration 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 In 2017, the FDA released draft guidance to accelerate approval.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 separations of researchers, manufacturers, and clinical servicers may slow commercialization more than FDA approval.

In addition to the expertise of the 7 start-ups and 3 FDA approved projects Webster Nanomedicine Lab’s where this work was conducted, we interviewed a number of start-ups and established nanomaterial manufactures. See our publication in Trends in Biotechnology