On Sept. 23, the U.S. Food and Drug Administration published a new proposed rule amending Title 21 of the Code of Federal Regulations, Subsections201.128 and 801.4 — the regulations defining "intended use."
Although the proposed codified language removes the knowledge-only prong from the definition — a helpful development from the industry's perspective —it also adds a potentially limiting proviso and a new provision that would allow the FDA to regulate a product based on its "design or composition."
The proposal represents the latest development in a long-running proceeding in which the FDA has both recognized the importance of clarity in these critical provisions and created confusion within industry regarding the scope of government's medical product jurisdiction and enforcement authorities.
The 30-day deadline for comments, while appealing from the standpoint of quickly finalizing the rule, also presents a challenging calculus for stakeholders in the current political climate.