Combination products
Combination products are medical products that combine a drug, device, and/or biologic into a single entity. These products are intended for use in diagnosis, treatment, or prevention of diseases or conditions. Examples of combination products include drug-eluting stents, prefilled syringes with drugs, and drug-device combination products for inhalation.
Regulation of combination products
Regulation of combination products by the FDA involves a coordinated approach that considers the constituent parts of the combination and their respective regulatory pathways. The FDA has established the Office of Combination Products (OCP) to oversee the regulation of these products. Here’s how combination products are regulated by the FDA:
Primary mode of action (PMOA)
The FDA determines the primary mode of action (PMOA) of a combination product to classify it into one of three categories: drug-device, biologic-device, or drug-biologic. The PMOA is the mode of action of the product that provides the most important therapeutic action.
Primary regulatory pathway
Based on the PMOA determination, the combination product is assigned to the regulatory pathway corresponding to its primary mode of action. For example:
- Drug-device combination products are primarily regulated under the drug or device regulations, depending on whether the drug or device component provides the primary therapeutic effect.
- Biologic-device combination products are primarily regulated under the biologics or device regulations, based on the primary therapeutic effect.
- Drug-biologic combination products are regulated under the regulations applicable to drugs or biologics, depending on the primary mode of action.
Regulatory review process
The FDA conducts a unified review of combination products, involving expertise from relevant FDA centers (e.g., Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), or Center for Biologics Evaluation and Research (CBER)). This ensures a comprehensive evaluation of the product’s safety, efficacy, and quality, considering all constituent parts.
Inter-center consultation
In cases where a combination product involves multiple FDA centers, the OCP facilitates inter-center consultations to ensure consistent and coordinated regulation. This involves collaboration between the respective centers to address regulatory issues and provide guidance on product development and approval.
Applicable regulations and guidance
Manufacturers of combination products must comply with relevant regulations and guidance documents specific to their product type and primary regulatory pathway. This includes requirements related to premarket submission, good manufacturing practices (GMP), labeling, post-market surveillance, and adverse event reporting.
FDA’s oversight role
The FDA continues to provide oversight throughout the lifecycle of combination products, including pre-market approval, post-market surveillance, and compliance activities to ensure ongoing safety and effectiveness.
Conclusion
In summary, combination products are regulated by the FDA through a coordinated approach that considers the constituent parts and their primary modes of action. The OCP plays a central role in overseeing the regulation of these products, ensuring consistency, and facilitating inter-center collaboration to address regulatory challenges effectively.
