FDA Finalizes Guidance on Drug/Device Combination Product Classifications

October 3, 2017

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.

View today's stories