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Regulatory Focus™ > News Articles > FDA Finalizes Combination Product Classification Guidance

FDA Finalizes Combination Product Classification Guidance

Posted 26 September 2017 | By Michael Mezher 

FDA Finalizes Combination Product Classification Guidance

The US Food and Drug Administration (FDA) on Tuesday issued its final guidance on classifying combination products as drugs, biologics or medical devices.

The guidance finalizes and combines two 2011 draft guidances, Classification of Products as Drugs and Devices & Additional Product Classification Issues and Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug and Cosmetic Act, and details how FDA makes product classification decisions and outlines the request for designation (RFD) process.


Combination products are products that combine two or more different types of FDA-regulated products. When it comes to reviewing combination products, FDA makes a determination as to how the product will be classified and which of its offices will carry out its premarket review.

How a combination product is classified can have a major impact on a product's development, as the classification will determine whether the sponsor needs to submit a new drug application (NDA), biologics license application (BLA) or a 510(k) or premarket approval (PMA) application.

Final Guidance

According to FDA, the final guidance was updated for clarity and includes a revised discussion of the agency's interpretation of the term "chemical action" as it relates to the definition of a medical device.

The final guidance also features a new frequently asked questions section and two tables providing examples of products that achieve or do not achieve their primary intended purpose through chemical action.

For example, Aspirin (acetylsalicylic acid) achieves its primary intended purpose through chemical action because it inactivates an enzyme in the body in order to suppress the body's inflammatory response, while an abdominal adhesion barrier does not, as it achieves its primary intended purpose by physically separating tissue.

FDA also says it removed a discussion on reevaluating prior classification determinations that appeared in the draft classification guidance in response to comments from industry.

"FDA has had limited experience with reevaluating classification determinations as the issue rarely arises … We will continue to address the issue on a case-by-case, fact-specific basis as needed," FDA writes, adding that companies with questions about the classification of a currently marketed product or whether a previous classification should be relied on for a product in development should contact the Office of Combination Products.

FDA, Federal Register Notice

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