What To Know About FDA's 'Intended Use' Proposed Rule

Law360 (October 8, 2020, 5:26 PM EDT) -- On Sept. 23, the U.S. Food and Drug Administration published a new proposed rule amending Title 21 of the Code of Federal Regulations, Subsections 201.128 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...

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