- AdvaMed, the Combination Products Coalition and medical device maker Cook Group have weighed in on FDA’s plan to revise its rules for classifying medical products as either drugs, devices, biological or a combination. The distinction determines which arm of the agency oversees a product’s pre-market review and regulation.
- FDA says it is taking steps to modernize its regulations governing classification of combo products to encourage continued innovation and align with recent legislative measures. In May the agency proposed to amend how it regulates the classification of combination products.
- AdvaMed contends FDA’s proposed rule change on product jurisdiction ignores congressional intent on the definition of “primary mode of action.” The primary mode of action is the attribute of the product that is expected to make the greatest contribution to its therapeutic effect.
The medical device industry is concerned that FDA too often concludes a product’s primary mode of action is that of a drug or biologic rather than a device. The proposed rule omits a congressional restriction against determining primary mode of action based solely on whether the product causes a chemical action within the human body, AdvaMed said in comments to FDA.
The device industry has an interest in having combo products treated as devices. The drug approval process typically requires years and several phases of clinical trials, while the path to market typically is less rigorous for medical devices.
Cook Group said FDA has a tendency to declare a product to be a drug “solely on the basis of the theoretical or minimal amount of supposed chemical action in a product or constituent part that is a device.”
FDA is overlooking a provision in the 21st Century Cure Act aimed at “addressing the problem that Congress identified with FDA’s drug-centric classification approach,” according to AdvaMed.
“The problem is over-inclusive assessment of chemical action as a basis for drug classification. The solution to this problem is to make plain in the amended classification regulations that FDA will not classify products as drugs based solely on any chemical action,” AdvaMed said.
The industry group recommended FDA include the following language in the revised rule: “In determining the primary mode of action of a combination product, FDA will not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.”
The Combination Products Coalition said it would like clarification on jurisdiction for cross-labeled combination products and devices that provide dosing recommendations on the basis of digital health technology, such as wearables that monitor physiological parameters or track dosing compliance.