Originally Published MDDI December 2002
NEWS & ANALYSIS
James G. Dickinson
AdvaMed is opposing FDA's proposed jurisdictional change from CDRH to the Center for Biologics Evaluation and Research (CBER) for combination wound-repair products that contain live cellular components. In a letter to FDA general counsel Daniel Troy, AdvaMed cited FDA's newly articulated proposal stating that the basis for making jurisdictional changes is a product's "primary mode of action." This interpretation, AdvaMed wrote, "departs fundamentally from past policy pronouncements and practices; imposes profound costs and other adverse consequences on affected entities; and, consequently, requires notice-and-comment rulemaking. . . ."
AdvaMed argues that the jurisdictional shift is inappropriate for this class of products under the statutory definition of biological product. To justify the change, the group says, FDA must demonstrate a "strong public health or other compelling basis for the change."
FDA first proposed the jurisdictional shift in a May 15 Federal Register notice. Most of these products have been characterized so far as "cultured skin," FDA said, and have been filed and reviewed by CDRH as PMA applications. The agency is now questioning whether the devices should not be transferred to CBER for premarket review.
The letter can be viewed in an on-line Adobe file at http://www.advamed.org/publicdocs/81502troyltr.pdf.
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