On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations. In its current form, the regulations have created long-standing confusion as to whether mere knowledge of an unapproved use of an approved product (i.e., off-label) automatically triggers a new “intended use,” for which clearance or approval is required. The proposed rule clarifies that knowledge alone of off-label use would not create a new intended use, but confirms the Agency’s long-standing position that “any relevant source” of evidence (including knowledge) may be used to determine intended use. Comments on the proposed… Continue Reading FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence
Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office.