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Medical Devices / Regulatory Affairs

FDA Finalizes Guidance on Drug/Device Combination Product Classifications

Oct. 4, 2017
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The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device.

The final document replaces two drafts published in June 2011, encompassing product classification issues, requests for designations, the legal definition of a medical device and interpreting the term “chemical action.”

The guidance is divided into two sections: information for sponsors seeking a formal determination of their product’s classification and obtaining feedback from the FDA on related questions; and on the general concepts and definitions relating to the agency’s decision-making process.

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