FDA should issue draft guidance defining "primary mode of action" before moving forward with rulemaking to codify the term, according to AdvaMed.

Although primary mode of action (PMOA) is the principle by which the agency assigns regulatory jurisdiction for combination products, the statutory term has never been formally defined.

Because assignment of a given product to a therapeutic center has implications for premarket and postmarket regulation of that product, the issue of PMOA interpretation has generated much debate, leaving the device industry eager for agency clarification regarding the key term.

However, in February comments to FDA, AdvaMed asks that "the agency not move hastily to codification" of PMOA.

It would be "prudent to proceed first through a draft guidance notice-and-comment process" in order to work out any problematic aspects posed by unforeseen emerging technologies, AdvaMed writes.

"Once there has been sufficient experience with the definition and appropriate refinements are made based on that experience, the agency then could consider a final guidance or rule at a later date," the trade group suggests.

AdvaMed's comments respond to an ¹ October 2003 report to Congress on activities and impacts of FDA's Office of Combination Products (OCP).

The statutorily mandated report covers a number of initiatives undertaken by OCP, including its progress in categorizing and tracking combination product assignments and consults and the establishment of a number of working groups aimed at smoothing the path to market for combination products (² Also see "Combination Products Office Meeting 100% Of Review Goals At Nine Months" - Medtech Insight, 20 October, 2003., p. 9).

In the report, the agency writes that PMOA clarification efforts likely will be achieved through "proposed rulemaking to revise 21 CFR Part 3 to include a definition of 'primary mode of action.'"

Last year, OCP created an internal working group to draft and test definitions for PMOA (³ Also see "Primary Mode Of Action Definition Assessment In Progress – FDA" - Medtech Insight, 7 April, 2003., p. 12).

Despite subsequent FDA assurance that the agency would be receptive to stakeholder comments, AdvaMed's response stresses the need for a formal comment period.

"Given the continuing technological innovations in the combination product area, it is probable that certain products will not have been anticipated during the definition development process," the trade association maintains.

AdvaMed also requests that OCP allow the trade association to work closely with the agency on developing combination product policy related to other premarket and postmarket concerns.

The October report includes statistics showing that most combination products involve device components. Thus, AdvaMed argues it should be allowed to work with FDA to craft combination product policy.

For example, AdvaMed points out that "for the seven- month period covered by the report, the vast majority of combination product premarket reviews (i.e. 71 of 80) involved CDRH as a primary or consulting center."

"Given the significant impact of the collaboration and or consultation premarket review process on the device industry," AdvaMed should be "permitted to work closely with OCP in development of guidance in this area," the association maintains.

Drug-device combinations are the most common type of combination product and CDRH requested 40 inter-center consultations with the drug center, OCP stats show.

The OCP report reflects information collected from the office's Dec. 24, 2002 inception through the end of last July. The premature cutoff was necessary in order to meet an October deadline.

However, OCP is proposing that its next report to congress be issued at the end of the calendar year so that the office may include a full fiscal year of combo product data.

Going forward, OCP also is considering scaling back its quarterly stakeholder updates, instead issuing a mid-year stakeholder update in addition to the mandated end-of-year report to Congress.

AdvaMed Cautions FDA Against Rush To “Primary Mode of Action” Rule

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