The FDA's regulation of premarket approval in cross-labeled combination products
JIANG Jian-ping
SHAO Ying
Abstract：Cross-labeled combination product is a unique type of regulatory approach in the United States for combination products,ensuring the clinical safety and effectiveness of the independently packaged drugs and medical devices when used together.This article provides an overview of the FDA's regulatory framework for cross-labeled combination products from the perspectives of product definition,regulatory bodies,premarket pathways and procedures,as well as relevant regulations.It also analyzes the current status of the FDA's premarket regulation for cross-labeled combination products,using ten FDA-approved photodynamic products as examples,along with other relative cases.
Keywords：combination productslabelingcross-labelingconstituent partpremarket approvalregulationphotodynamic product
Publication Date：2025-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：11( 922-932 )