Combination Products

A drug-device combination product combines two or more different types of regulated components, such as a drug and a medical device. Examples include prefilled syringes and certain auto-injectors. Applicable FDA requirements depend on the product’s components, classification, intended use, and regulatory pathway. RCA helps companies assess regulatory requirements, plan product development, and align quality systems with applicable drug and device regulations

FDA 21 CFR Part 4 establishes current Good Manufacturing Practice requirements for combination products, including how applicable drug and device requirements are applied to different product configurations. Companies must evaluate the requirements relevant to their combination product and manufacturing operations. RCA helps organizations assess compliance gaps, integrate quality system processes, and develop strategies to address applicable combination product requirements.

Companies should identify the applicable drug, device, and/or biologic requirements for their product and establish quality processes that address the relevant requirements without creating unnecessary duplication. Key considerations may include design controls, manufacturing controls, CAPA, change management, supplier quality, and documentation. RCA provides quality system assessments and consulting support to help companies align their quality systems with combination product regulatory expectations.

Determining a combination product’s regulatory pathway requires evaluating its constituent parts, intended use, primary mode of action, and applicable FDA requirements. Depending on the product, regulatory planning may involve different FDA centers and submission types. RCA supports regulatory strategy and product development planning to help companies understand applicable requirements, prepare submissions, and address regulatory questions throughout development.

Combination product manufacturers should review applicable quality system requirements, verify the availability and accuracy of documentation, assess manufacturing and validation controls, and ensure personnel understand their responsibilities. Companies should also evaluate potential gaps between drug and device processes. RCA provides inspection readiness, quality system assessments, and remediation support to help combination product organizations prepare for regulatory scrutiny.