Drug-device combination products: regulations and documentation

Drug-device combination products: regulations and documentation - Viky Verna

9:00 AM - 9:45 AM


Over the last years, the number of drug-device combination products entering the global market has increased significantly, mainly due to advances in medical technology as well as increase in user demand. While these products hold great promise for the future of healthcare treatment (e.g. simplified delivery, home use, compliance and adherence, user satisfaction, treatment options), bringing them to market involves a number of regulatory challenges, particularly within the US and the European Union (EU).
Combination products involve two or more regulated product categories; therefore, they include all the challenges presented by their individual constituents (i.e., the drug, device and/or biological product comprising the combination product that are not combined in to a single entity) as well as new issues that arise from the combination. Often, the barriers to combination product development and regulation arise from different perspectives as much as from scientific and/or technical challenges.
This presentation will provide insight to the regulatory framework for drug-device combination products in both the US and the EU and outline the unique regulatory challenges in both jurisdictions. The following questions will be addressed: What characteristics make a device a drug-device combination product and what makes it different from a medical device? What are the underlying requirements regarding the technical documentation? What medical writers need to know while preparing such documentation?