FDA FINAL RULE CLARIFIES PRIMARY MODE OF ACTION FOR COMBINATION PRODUCTS
The FDA's final rule defining the primary mode of action (PMOA) of combination products will give firms a better understanding of how the agency determines which FDA office takes regulatory oversight of their products, says an FDA official.
The document, released Aug. 24, sets forth an algorithm that the FDA will use to assign combination products when the agency cannot determine with "reasonable certainty" which mode of action "provides the most important therapeutic action of the combination product" -- which is the definition of PMOA.
The FDA uses PMOA to determine which of its centers -- drugs, biologics or devices -- has jurisdiction over a combination product. A proposed rule on PMOA was issued in May 2004.
There were only a handful of minor changes made to the proposed rule, said Mark Kramer, director of the FDA's Office of Combination Products. "The final rule largely codifies principles that we have already been using," he told FDAnews.
Areas of the rule that did undergo some changes, according to Kramer, were the sections on "intended use" and "precedence" -- both of which were clarified to further explain how they are used to determine a product's PMOA. The agency also responded to industry requests for additional examples of combination product scenarios. The final rule includes 11 examples -- as compared to three examples in the proposed rule -- of the FDA's decisionmaking process in determining jurisdiction of real and hypothetical products.