The Food and Drug Administration (FDA) is composed of six major centers; Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), Center for Tobacco Products (CTP), and Center for Veterinary Medicine (CVM) [1]. Each of these six centers are specialists in unique categories that fall under the FDA umbrella for regulations and each function autonomously. Certain centers have working relationships, such as CDER and CDRH, due to overlap in certain manufactured products. When bringing a product to market, it is important to know which center will regulate it.
Product development and manufacturing of a product can lead to overlaps within this organizational structure. CBER, CDRH, and CDER commonly overlap for the manufacturing of combination products. These are products that can combine drugs, devices, and/or biological products, such as a syringe that contains a drug or biologic [2]. If both the medical device and the drug or biologic are produced by the same manufacturer, then they would need to be registered as both a device manufacturer (though CDRH) and as a drug or biologic manufacturer (though CDER or CBER). This can get a bit more convoluted if only one of these products is produced by the manufacturer and the other component is produced elsewhere.
Ultimately, knowing the type of product you are attempting to bring to market as well as its classification is crucial for its success and the speed at which it makes it to market. Errored submissions typically lead to large delays and end up costing more.
If you need help understanding the regulatory pathways and which FDA organization will be regulating your product for FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] FDA. (2020, January 13). FDA Organization. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-organization
[2] FDA. (2019, June 18). About Combination Products. U.S. Food and Drug Administration. https://www.fda.gov/combination-products/about-combination-products
