The Food and Drug Administration recently released two draft guidance documents for review and comments detailing how it classifies certain products and defines the term “chemical action.”
These guidance documents could be the beginning of a major shift in the way certain orthopedic devices are reviewed. Here are highlights from each:
This guidance provides clarification on what FDA considers a device versus a drug and when the classification could extend to a biological or combination product. The broader drug definition encompasses devices, however; FDA predominantly uses the drug definition when determining classifications. FDA provides information of how to receive formal feedback on your product’s classification, and elaborates on interpretive phrases within the FDA device definition, specifically:
“similar or related article,”
“does not achieve its primary intended purposes through chemical action within or on the body of man,” and
Similar or related articles can be considered anything that still falls under the device definition, but is not directly listed in the device definition (e.g. liquids, semi-liquids, gels, gases, or powders). The phrase “chemical action” encompasses a broad category of biological responses and is described in greater detail in the newly released draft guidance (see below). When a product meets the drug and/or device definition(s) and it also meets the definition of a biological product, the product could be classified as any of the three: device, drug and/or biologic. For questions concerning combination products, FDA recommends contacting the Office for Combination Products (OCP).
In the case your product meets several of the classification definitions and/or you’re still unsure of the most appropriate definition for your device, you can file a request for designation (RFD). FDA will respond within 60 days (or not if they accept the sponsor’s classification) with a classification of drug, device, biological, and/or combination product.
It is also important to note that non-binding intercenter agreements within the Agency exist and device classifications are made on a case-by-case basis so you should not assume a certain classification based on a decision for a similar device.
Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
This guidance provides further clarification on how FDA interprets the term “chemical action” in the device definition. If a product achieves its primary intended purpose through chemical action within or on the body of man, then it is not considered a device. So how does FDA define “chemical action?”
When a product mediates a bodily response at the cellular or molecular level or combines with or modifies an entity so as to alter that entity’s interaction with the body of man or other animals through either chemical reaction or intermolecular forces or both, then FDA considers this “chemical action.” FDA provides several common examples within the guidance ranging from the formation of covalent bonds to selective binding of a chemical agent to a molecular target/receptor to catalytic and surfactant action.
Can we expect to see shifts in the review of certain orthopedic devices? Bone void fillers have been regulated as devices, but the newly published definition seems to imply bone void fillers could be regulated differently if FDA takes the position these calcium salt-based devices are mediating a cellular response.
Michelle can be reached at firstname.lastname@example.org.