Stakeholders will have an opportunity to comment on FDA's planned interpretation of "primary mode of action," according to agency officials.

FDA is evaluating various definitions for PMOA, the principle by which the agency assigns jurisdiction for combination products, Office of Combination Products Director Mark Kramer said April 2 during the Food & Drug Law Institute annual educational conference in Washington, D.C.

"We have a working group that...has been meeting for several months, and we have developed a few possible definitions for primary mode of action," Kramer reported. "We are reviewing these potential definitions against a series of test cases to see if, in fact, the definitions get us where we want to be." FDA is looking for a PMOA definition that "will provide more consistency, more predictability and more transparency to the assignment process."

The process of choosing a PMOA definition itself also should be transparent, Quintiles Consulting VP-Medi-cal Device Development David West urged. He argued that the regulated industry should be allowed to provide input on the definition because it not only will "have enormous consequences for the products and how they develop, but also how the products should be ultimately paid for."

The issue is "very much a work in progress," Kramer noted. There will be "transparency and an opportunity to comment" when the agency is further along, FDA Associate Chief Counsel for Biologics Catherine Cook assured West.

The agency has held two public meetings on combination products. The issue of how to interpret primary mode of action was a topic that generated much debate in the past (¹ Also see "FDA Will Accept Primary Mode Of Action Definition Comments Until Jan. 24" - Medtech Insight, 2 December, 2002., p. 5).

Stakeholders have suggested that the agency should review previous decisions in searching for underlying principles for assigning product jurisdiction. Kramer noted that FDA has created a database of precedents: "We are already finding it to be easier to make decisions, because we are able to search the information in our previous decisions," he said, adding that the agency ultimately plans to incorporate roughly 300 historical decisions in the database.

Primary Mode Of Action Definition Assessment In Progress – FDA

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