FDA's Office of Combination Products coding system and intercenter consultations database are providing the agency with a first look at OCP's early performance on reviews involving more than one center.

"Until recently we didn't have a good idea of the number of combination products we were reviewing -submissions didn't have a flag," Office of Combination Products Director Mark Kramer told AdvaMed's "Demystifying Combination Products" seminar Oct. 14 in Alexandria, Va.

The new coding system, however, has revealed that 1% of device center submissions considered since the spring involve a combination product, the director estimated.

"We want to know what these products are, and how they're doing in the agency. So we have a system now where all premarket submissions are categorized whether or not they include a combination product, and if so, what type," Kramer explained.

The categorization scheme assigns one of nine different codes, ranging from "not a combination product" to devices "co-packaged or co-labeled" with a drug or biologic.

The new procedure has helped the agency to clarify performance data sought by industry. For instance, in its first nine months of operation - from Dec. 24, 2002 to Sept. 30, 2003 - OCP has issued all 13 of its assignments within the 60-day period mandated by the Medical Device User Fee & Modernization Act with a mean review time of 38 days, Kramer reported.

During that timeframe, eight drug-device combos were assigned to CDRH and three to FDA's drug center, while CBER was assigned one drug-biologic and one device-biologic combination. One request for designation was withdrawn, and another is pending.

Kramer further commented that "we're also tracking combinations that don't require intercenter consultation." Despite FDA's desire for cooperation between centers, "after a while, the review becomes 'routine-ized,' and probably most combination products do not need consultation," he said.

To assist office coordination of activities between centers, OCP also is launching an "active monitoring" web database for the consultations. "We have a paper method that's being used, but it's soon going to be updated by a database that will be accessible by reviewers in all three centers," Kramer said.

"It's going to allow us to track these consults much better - we'll make sure that the request is clear, that the timeframe is appropriate, and that the consulting center understands what's expected of them and can meet the requested deadline."

Kramer expressed confidence that the new efforts are sufficient to designate and monitor combination product reviews, in contrast to the establishment of a combo products center favored by many industry representatives.

Limited FDA resources, combined with combination product diversity, preclude the establishment of a separate center or general guidance document, Kramer said. "I don't think we'll ever get to that - it would have to be as big as other centers; one size doesn't fit all," he averred.

Further clarification is forthcoming, however. In line with MDUFMA's vision for a more predictable product designation process, the agency plans for release of a primary-mode-of-action proposed rule for public comment and review. An FDA action working group has been developing proposals on the rubric used to designated combo products since early this year (¹ Also see "Primary Mode Of Action Definition Assessment In Progress – FDA" - Medtech Insight, 7 April, 2003., p. 12).

In the meantime, the OCP director advised manufacturers to consider postmarket regulation of combination products earlier in their regulatory development. Such considerations tend to "go by the wayside until late in the process," he said. Baker & Daniels associate Danelle Miller Marks supported Kramer's call for early integration of postmarket considerations.

Separately, China's State Food & Drug Administration has a law "on the way" for combination products, currently regulated by special SFDA "notices" and ad hoc decisions, according to Baker & Daniels attorney Xiang Wang. Establishment of a Chinese Office of Combination Products and elimination of double registrations for comparison reports and clinical trials are among measures that could be included in the statute.

Combination Products Office Meeting 100% Of Review Goals At Nine Months

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