Regulatory Strategies for Global Approval of Biologic–Medical Device Combination Products: FDA, EMA, and International Perspectives

Abstract

Biologic–medical device combination products represent one of the fastest-growing and most scientifically complex categories of healthcare products. These products integrate biologics, including monoclonal antibodies, vaccines, recombinant proteins, cell therapies, and gene therapies, with medical devices that facilitate delivery, administration, monitoring, or therapeutic performance. Examples include prefilled syringes, autoinjectors, wearable injectors, infusion pumps, inhalation systems, and advanced therapy delivery platforms. The increasing prevalence of chronic diseases, the transition toward patient-centric healthcare, and advances in biotechnology have accelerated the development and commercialization of combination products worldwide [1,3–5].

Despite their clinical and commercial advantages, biologic–medical device combination products present significant regulatory challenges because they must satisfy requirements applicable to both biologics and medical devices. Regulatory authorities are required to evaluate not only the safety, efficacy, and quality of individual constituent parts but also the performance, reliability, usability, and risk profile of the integrated product throughout its lifecycle [11–20]. Differences in product classification, primary mode of action (PMOA) determination, quality management systems, clinical evidence requirements, and post-market surveillance obligations further complicate global development and regulatory approval strategies [3,11,12,32–38].