Home Services Combination Product Testing Which organization regulates the testing of combination products?
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Which FDA center regulates the testing of combination products?


The structure of regulation within the FDA requires that a combination product be evaluated within the CDRH as a medical device AND the CBER as a drug. When you are designing and validating packages for combination products, the packaging provisions of both agencies must be considered.

CDRH - FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

CBER - CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.