What regulatory guidance provides a pathway for combination products?

The FDA's Combination Products Guidance specifically outlines the regulatory framework and pathways for products that fall into the combination category. Combination products are those that comprise two or more regulated components, such as a drug-device combination or a biologic and device together. This guidance defines how these products are to be classified, the applicable regulatory requirements, and the roles of the involved centers within the FDA, such as the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER).

This guidance is crucial because combination products can present unique challenges that do not fit neatly within the regulatory processes established for single-entity products. The FDA's guidance provides clear instructions on premarket submission types, review procedures, and postmarket considerations, facilitating the development and approval process for these innovative products.

In contrast, the other options, while related to combination products, do not serve as the primary regulatory guidance in the context of the FDA's framework. The EU's Regulation on Combination Products may address similar concerns for the European market, but it is distinct from the FDA's guidelines. The WHO's Guidelines and ISO Standards provide frameworks for quality and safety but do not focus explicitly on the regulatory pathways specific