AUTHOR=Rodríguez-Gómez Francisco D. , Monferrer Dominique , Penon Oriol , Rivera-Gil Pilar 

TITLE=Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

JOURNAL=Frontiers in Medicine

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1544393

DOI=10.3389/fmed.2025.1544393

ISSN=2296-858X

ABSTRACT=The integration of nanotechnology into healthcare has introduced Nanotechnology-Enabled Health Products (NHPs), promising revolutionary advancements in medical treatments and diagnostics. Despite their potential, the regulatory navigation for these products remains complex and often lagging, creating barriers to their clinical application. This review article focuses on dissecting the regulatory landscape for NHPs, particularly in the European Union and the United States, to identify applicable requirements and the main regulatory guidelines currently available for meeting regulatory expectations.