The guidance details how the FDA makes product classification decisions and addresses issues that may arise in determining whether products should be classified as drugs or devices. It also provides details about the agency’s interpretation of the term “chemical action” and addresses the request for designation (RFD) process for securing a formal determination of a product’s classification.

The FDA’s finalized guidance places a particular focus on cases in which a combination product may be classified as a drug or device. The document stresses the importance of this classification in determining whether the sponsor needs to submit a new drug application (NDA), biologics license application (BLA), or a 510(k) or premarket approval (PMA) application.

The FDA’s determination of whether to classify a product as a drug or a device is based on statutory definitions set forth in the Food, Drug, and Cosmetic (FD&C) Act. As the guidance explains, designations are based primarily on whether a product meets the definition of a medical device under Section 201(h) of the FD&C Act, since all FDA-regulated medical products conceptually meet the legislation’s broader definition of “drug.” The former, more restrictive definition requires that a product:

  • Be an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that doesn’t achieve its primary intended purpose via chemical action within the body. The issue of whether a product may be considered a “similar or related article” under this clause can arise, for example, with regard to products in liquid, semiliquid, gel, gas or powder form. The guidance notes that a product displays chemical actions if it interacts at the molecular level with bodily components (e.g., cells or tissues) to mediate a bodily response, or with foreign entities (e.g., organisms or chemicals) so as to alter that entity’s interaction with the body;
  • “Does not achieve its primary intended purposes through chemical action within or on the body of man or other animals”; or
  • “[Is] not dependent upon being metabolized for the achievement of its primary intended purposes.”

The final guidance features an FAQ section and two tables providing examples of products that achieve or fail to achieve their primary intended purpose through chemical action.

The guidance recommends that sponsors contact the Office of Combination Products if they wish to discuss a product for which the appropriate classification is unclear or in dispute. Also outlined is the RFD process for obtaining a formal determination of a product’s classification.

The guidance brings together 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.