> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Delays ‘Intended Use’ Changes to Review Stakeholder Concerns
- URL: https://www.fdaweb.com/fda-delays-intended-use-changes-to-review-stakeholder-concerns/
- Published: 2018-01-12T12:00:00.000Z
- Updated: 2026-09-14T23:13:17.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5140492

FDA is delaying the effective date of portions of a final rule that would have revised the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended use. Comments to FDA from stakeholders complained that the proposed changes were not clear, and the agency says in a [just-posted notice](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592358.htm?utm%5Fsource=dlvr.it&utm%5Fmedium=twitter) that the delay will give it extra time to address the concerns.  

The new intended use language relates to existing regulations that describe the types of evidence FDA may consider when determining how a manufacturer intended for its product to be used by doctors and patients. “This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products,” the notice says. “How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work. The new language on intended use that was included in the final rule was not in the proposed rule.”

In earlier comments to FDA, three industry trade groups reiterated their opposition to the rule. [Comments](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-N-2002-2003&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) from the Medical Information Working Group (MIWG) say the final rule raises two significant issues — it exceeds the scope of FDA’s authority under the Federal Food, Drug, and Cosmetic Act, and it violates the Administrative Procedures Act by adopting the “totality” language without adequate notice. MIWG says the rule would put manufacturers in the position of having to either discontinue communication practices that FDA has acknowledged advance public health objectives or risk being held liable for enforcement actions. It also says the rule is legally problematic because it “radically departs from the well-established statutory interpretation of intended use reflected in the applicable legal authorities, including the legislative history.”

According to a Pharmaceutical Research and Manufacturers of America (PhRMA) comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-N-2002-2001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com), FDA may establish that a manufacturer has a particular intended use for an article only when the manufacturer has made a promotional claim about that use to a third party. “The final rule adopts an expansive ‘totality of the evidence’ standard under which a particular ‘intended use’ may be established even absent any external manufacturer claim about that use,” the letter says. “Such an approach is simply not supported by the case law. We are aware of no case in which a court has found that an ‘intended use’ of a product was established absent an external claim by the manufacturer about the use.”

PhRMA also says the final rule would, in some circumstances, inappropriately restrict important speech about unapproved uses of FDA-approved medical products that could be beneficial to both healthcare professionals and the patients they serve.

  
Finally, AdvaMed says in a [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-N-2002-2004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) that since the intended use of a medical product is a foundational concept in the application of the Federal Food, Drug, and Cosmetic Act, “it is crucial that FDA’s definition of ‘intended uses’ provide manufacturers with clear guidance and take care not to sweep broadly into permitted and protected exchange of truthful, non-misleading information. Unfortunately, FDA’s 1/9/17 final rule on the definition of intended uses … does neither.” The association calls on the agency to “abandon the final rule and adopt a clear and appropriate definition of ‘intended use.’” Should the agency not take that step, AdvaMed says, it should, at a minimum, adopt a standard for determining “intended uses” that makes clear that **(1)** legitimate, protected scientific exchange, **(2)** truthful, non-misleading communications (including commercial speech), and **(3)** mere knowledge of unapproved use by third parties do not constitute evidence of an “intended use.”