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# Stakeholders Ask ‘Intended Use’ Rule Stay and Reconsideration
- URL: https://www.fdaweb.com/stakeholders-ask-intended-use-rule-stay-and-reconsideration/
- Published: 2017-02-09T12:00:00.000Z
- Updated: 2026-09-14T22:05:40.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137945

The Medical Information Working Group, Pharmaceutical Research and Manufacturers of America, and Biotechnology Information Organization have petitioned FDA to indefinitely stay the agency’s 1/9 [final rule](https://www.fdaweb.com/will-trump-administration-scrap-intended-use-new-rule/) relating to intended uses of drug, medical devices, and combination products and to reconsider the final rule. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-N-1149-0048&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says that agency staff should be directed to promulgate final definitions of intended use that are consistent with the proposed definitions set out in a 9/25/15 notice of proposed rulemaking. FDA has already announced delayed implementation of the 1/9 rule to give the Trump administration time to consider what it wants to do with it.

According to the petition, FDA’s unexpected decision to revise the definitions of “intended use” to include a new “totality of the evidence” standard was not communicated to the public prior to publication, depriving stakeholders of fair notice and an opportunity to be heard in violation of the Administrative Procedure Act.

“If allowed to take effect,” it says, “the provisions would run contrary to the settled interpretation of both the statutory definitions that turn on ‘intended use’ in the Federal Food, Drug, and Cosmetic Act (FFDCA) and the requirement that drug and device labeling include ‘adequate directions for use.’”

The stakeholders say there are two reasons why the rule should be stayed indefinitely and reconsidered. First, they say, it violates the Administrative Procedures Act, as noted above, for failing to provide fair notice or a meaningful opportunity to comment to parties subject to potentially significant and far-reaching liability. And second, while FDA claims that the final rule is merely a clarification of law, in reality it adopted a new “totality of the evidence” standard for finding an intended use that it not found in the FFDCA or the case law addressing the intended use question.