FDA Provides Guidance on Classifying Medical Products

The Food and Drug Administration (FDA) recently issued final guidance on the classification of medical products. FDA, Final Guidance for Industry and FDA Staff, Classification of Products as Drugs and Devices and Additional Product Classification Issues (Sept. 2017). With the Guidance, FDA seeks to provide additional clarity and predictability for the medical product industry. (Id.at 2.)

Formal Classifications Can Be Obtained with Requests for Classification

To obtain a formal classification for a product as a drug, device, biological product, or combination product, medical product sponsors can submit a Request for Designation to FDA’s Office of Combination Products. (Id. at 3.) Requests should include a recommended classification and bases for the recommendation. (Id.) The Office will respond to the Request in writing within sixty days; if not, the recommended classification becomes final. (Id. at 3-4.)

If FDA does not adopt the recommended classification, the sponsor can request reconsideration. (Id. at 4 n.8.) The sponsor can also submit a new Request for Designation if it develops or becomes aware of new information relevant to the product’s classification. (Id.) FDA can modify final classifications only with the sponsor’s written consent or for public health reasons based on scientific evidence. (Id. at 4.)

FDA Looks to Statutory Definitions When Classifying Products

All FDA-regulated medical products qualify as "drugs" under the statutory definition. (Id. at 5.) If a product also meets the definition of "biological product" but not "device," FDA will generally classify the product as a biological product. (Id. at 11.) If a product meets the definitions of "drug" and "device," but not "biological product," FDA will generally classify the product as a device unless it falls within a special category. (Id. at 12.) If a product meets all three definitions, its classification is less clear and FDA recommends that sponsors of such products contact the Office of Combination Products about classification. (Id.)

FDA Provides Clarity on the Definition of "Device"

The definition of "device" requires, inter alia, that the product (1) be an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article; and (2) have primary intended purposes that are not achieved through chemical action within or on the body. (Id. at 5.)

A. "Other Similar or Related Article"
The Guidance indicates that some products in liquid, semi-liquid, gel, gas, or powder form qualify as "other similar or related articles." (Id. at 6.) For example, FDA considers gels or powders put on the skin as a barrier, gases used as space fillers, and liquids used to clean either surgical instruments or contact lenses as "other similar or related articles." (Id.)

B. "Chemical Action Within or on the Body"
The Guidance indicates that some products involving chemical action qualify as devices. (Id. at 6-7.) Chemical action occurs when a product interacts at the molecular level with bodily components (e.g., cells or tissues) to mediate a bodily response, or with foreign entities to alter the entities’ interactions with the body. (Id.) Interaction at the molecular level includes chemical reaction and intermolecular forces, not a mere exchange of non-chemical energy, such as electromagnetic or thermal energy. (Id. at 7 n.12.)

Products involving chemical action can qualify as devices if the chemical action does not achieve the products’ primary intended purposes. (Id. at 7.) For example, a hip joint replacement implant that restores movement as its primary intended purpose is a device, even if the implant also elicits a foreign body response through chemical action. (Id.) An absorbable suture that rejoins tissue as its primary intended purpose is a device, even if the body resorbs the suture through chemical action. (Id.)

Products involving chemical action can also qualify as devices if the chemical action is not within or on the body. (Id.) For example, an antimicrobial agent used to clean a surgical instrument before use does not involve chemical action within or on the body. (Id. at 8.) FDA has also determined that the chemical action in a kidney hemodialysis machine and the chemical action in a transport solution for preserving donor organs do not occur within or on the body. (Id.)

Conclusion

FDA’s Guidance provides some clarity and useful examples as to when a product is classified as a drug or device. Medical product sponsors should consider the Guidance and related statutes and regulations early in product development, for example, to ensure that they are pursuing a workable classification and to better direct their scientific and regulatory efforts towards supporting a desired classification.