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This article aims to provide practical guidelines for the inclusion of medical devices in the electronic common technical document (eCTD), a traditionally drug-and-biologic‒oriented structure. The article outlines an approach to describe information on device development for drug-led combination product submissions (e.g., the biologics license application [BLA] and new drug application [NDA]). It also addresses regulatory considerations associated with notified body opinion (NBOp) in accordance with Article 117 of the EU Medical Devices Regulation (EU MDR)1 for medicinal products that incorporate a nonreusable medical device.
 
Keywords – combination products, submission contents, eCTD  
 

Introduction

Drug-device combination products can play a critical role in enhancing the therapeutic benefit of drugs, ensuring patient convenience, and reducing costs to the healthcare system. Pharmaceutical companies are investing in the development of delivery devices (e.g., prefilled syringes, autoinjectors, and on-body injectors) in response to the increasing access needs of patients. For these products, the US and EU regulatory landscapes and requirements continue to evolve. In the US, device information for drug-led combination products is routinely submitted under a drug or biologics application pathway (e.g., BLA, investigational new drug, or NDA) via a single marketing application.
 
Under the single application pathway, the device submission content is reviewed by the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) through an intercenter consulting process. However, there is currently no single comprehensive FDA guidance that describes the device submission content for drug-led combination products. In the EU, Article 117 of the EU MDR requires a marketing authorization holder of a medicinal product that incorporates a nonreusable medical device (or integral drug-device combination product such as a prefilled syringe) to obtain an NBOp confirming the device part is compliant with the relevant general safety and performance requirements (GSPR)2 in Annex I of the EU MDR.1 The positive NBOp is then included in the marketing authorization application (MAA) or variation, as applicable.
 
This article will discuss the expectations for submission content and the best practices of the FDA and notified body (in accordance with EU MDR Article 117) for drug-led combination products and medicinal products that incorporate a nonreusable medical device, respectively.