On January 31, 2012, WLF filed supplemental comments with FDA, urging it to withdraw its draft guidance regarding the sale of Research Use Only (RUI) devices. FDA lacks jurisdiction to regulate devices when the manufacturer’s only “intended use” for its product is medical research. But FDA can assert jurisdiction if the “intended use” includes providing medical diagnoses. FDA contends that some RUI devices are regularly used by their purchasers for diagnostic purposes, and that a manufacturer can be deemed to “intend” such uses if it becomes aware of those uses but does nothing to stop them. WLF argued that, under federal law, a manufacturer cannot be deemed to have “intended” the diagnostic use of its products merely because such use is foreseeable. WLF initially filed objections to the FDA draft guidance in August 2011; it filed its supplemental comments because of recent indications from FDA that it may begin enforcing the new rule even before issuing it in final form.
