Combination products: inspection readiness across product boundaries

Combination products bring drug, device, and/or biological components together. A useful preparation review first establishes the actual product and jurisdictional position, then maps the relevant requirements and interfaces.

Clarify ownership across the components

Consider component suppliers, assembly, filling, packaging, labeling, software where relevant, testing, release, complaints, and postmarket responsibilities. Avoid assuming a compliant component automatically establishes the suitability of the finished combination.

Trace one cross-boundary change

A practical exercise follows a component or supplier change through technical evaluation, quality review, manufacturing evidence, labeling assessment, and any regulatory action that is applicable. The exercise should expose assumptions and handoffs rather than predetermine the answer.

FDA’s combination-products directory links definitions, jurisdictional information, the Request for Designation process, and guidance. Use those resources to resolve the product-specific framework.

Related preparation and support

Browse short preparation briefs · Supplier qualification · Facility planning · Customized training inquiry · Contact us about your product scope