Rodríguez-Gómez, Francisco D.Monferrer, DominiquePenon, OriolRivera Gil, Pilar, 1976-2025-11-102025-11-102025Rodriguez-Gomez FD, Monferrer D, Penon O, Rivera-Gil P. Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks. Front Med (Lausanne). 2025 Mar 5:12:1544393. DOI: 10.3389/fmed.2025.15443932296-858Xhttp://hdl.handle.net/10230/71834The 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.application/pdfeng© 2025 Rodríguez-Gómez, Monferrer, Penon and Rivera-Gil. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/article2025-11-10http://dx.doi.org/10.3389/fmed.2025.1544393Nanotechnology-enabled health productsRegulatory pathwaysEuropean UnionUnited StatesHealthcare innovationMedical regulationsinfo:eu-repo/semantics/openAccess