Drug or Device – Who regulates your product?

The very first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product.

The primary centers at the FDA are:
CDRH – Center for Devices and Radiological Health
CDER – Center for Drug Evaluation and Research
CBER – Center for Biologics Evaluation and Research

Although, FDA has issued the guidance on product classification and most of the times the categorization between drugs, biologics and medical devices is easy but in some case this can be a challenge, especially if a product is a consumer product or mobile app with medical application or a combination product, injection, drug delivery system, products with novel mode of action etc. However, this distinction can be made easy by asking few simple questions:

1. How would you define your product; whether it meets the definition of a drug, biologic or a device? Because, FDA’s determination of whether to classify a product as a drug or device is purely based on statutory definitions, as set forth in sections 201(g) and 201(h) of FD&C Act, respectively.

2. What is the primary mode of action of your product to achieve its intended purposes? Because, two products with exactly the same composition can be classified differently based on their primary intended purposes and how they achieve it.

Sometimes the category you might think it should come under may not be the right one, or it could be overlapping. So, it has to be reviewed with respect to the indications of use and competitor products, if there are any. In case of confusion you can contact the Office of Combination Products for feedback.

Once you chose the right center you can hire the right regulatory expert who can navigate you through the whole regulatory process and not only efficiently get the product to market but also maintains the compliance throughout its life cycle.

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