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# ‘Intended Use’ Final Rule Analyzed
- URL: https://www.fdaweb.com/intended-use-final-rule-analyzed/
- Published: 2021-08-17T12:00:00.000Z
- Updated: 2026-09-14T17:10:54.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5149947

Attorney **Jeffrey Shapiro** (Hyman, Phelps & McNamara) has three takeaways from the recent FDA final rule governing how the intended use of a distributed product is to be determined. First, he says in an *FDA Law Blog* [post](https://www.thefdalawblog.com/2021/08/the-6-year-saga-finally-ends-fda-issues-final-rule-modifying-the-intended-use-regulation/?ref=fdaweb.com), the removal of the knowledge provision, which had seemed to problematically suggest that a manufacturer could be held responsible for off-label use if the manufacturer knew about it, “is a significant victory for regulatory clarity and brings the regulation more in line with the statutory scheme.”

Second, a new italicized proviso introduced in the rulemaking is important because it further prevents FDA from inferring off-label intent based merely on the knowledge that an otherwise lawfully marketed device is being used off-label.

And last, the revised provision gives the agency the right to consider “design and composition” in determining intended use, requiring that FDA limit the determination of intended use in premarket review to the proposed labeling.

Shapiro concludes that on the whole, the amended intended use regulation is “a modest improvement over the one in place for many decades