Rapport sur l'approbation de la FDA des dispositifs médicaux contenant des matériaux nanostructurés

Résumé

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 In 2017, the FDA released draft guidance to accelerate approval.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