On Tuesday 26th September 2017 the US Food and Drugs Administration (FDA) issued the final guidance document for “Classification of Products as Drugs and Devices & Additional Product Classification Issues”. FDA had previously issued two draft guidance documents in 2011 on this topic. The contents of this recently finalised document combine the information given in the two draft guidances.
Combination products that can include a combination of drugs, devices or biological products have raised many questions and concerns regarding their classification over the years. Therefore, the new guidance aims to provide “as much clarity and predictability as possible with respect to product classifications to enable informed planning for product development.”
The final guidance includes a revised discussion of the FDA’s interpretation of the term “chemical action” as it relates to the definition of a medical device. The document also includes a ‘Frequently Asked Questions’ section and tables that provide examples of products that achieve or do not achieve their primary intended purpose through chemical action.
The discussion section on re-evaluating prior classification determinations that appeared in the draft classification guidance in response to comments from industry, has been removed in the final document. The guidance states that: “FDA has had limited experience with re-evaluating classification determinations as the issue rarely arises.” The agency will therefore continue to address such issues on a case-by-case, fact-specific basis as required.
Companies with questions regarding the classification of their product that are currently on the market should contact the FDA’s Office of Combination Products.
Click here to access the guidance document.