After multiple delays, the US Food and Drug Administration (FDA) has finalized a rule clarifying its position on the types of evidence it will consider when determining a medical product’s intended use. The new rule also repeals and replaces the unimplemented portions of an earlier final rule on intended uses.
 
The final rule comes less than a year after the agency proposed it and is “largely unchanged from the proposed rule.” The only change from the proposed rule is a modification to the codified language of the intended uses regulation, “to clarify its applicability to devices that are approved, cleared, granted marketing authorization, or exempted from premarket notification.”
 
The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a proposed rule that was eventually revised and made final in January 2017, despite pushback from industry. However, before the rule took effect, FDA delayed its implementation by a month-and-a-half in February 2017, then by a year in March 2017, before delaying it indefinitely in March 2018.
 
The delays were prompted by confusion and concerns raised by pharmaceutical and biotech industry groups, who petitioned the agency to stay the rule and revert to its original proposal to delete two rarely enforced clauses, found in 21 CFR 201.128 and 801.4, that allow FDA to regulate products according to their actual uses based on whether a manufacturer “knows, or has knowledge of” information that would indicate that a drug or device will be used for other uses outside the product’s specified intended use.
 
When FDA released the proposed rule in September, the agency introduced new language clarifying that companies “would not be regarded as intending an unapproved new use for an [approved or cleared medical product] based solely on that firm’s knowledge that such [product] was being prescribed or used by health care providers for such use,” clarifying that the firm’s knowledge of an unapproved use would not, by itself, trigger new labeling obligations. FDA also insisted at the time that the proposed rule reflects the agency’s current interpretation of the intended use regulations and its existing policies and practices for determining a product’s intended uses.
 
In the final rule, FDA declined industry’s insistence that the agency narrow its interpretation of evidence of intended use to a firm’s promotional claims.
 
“Nothing in the statute requires the narrow scope that the comment suggested … The fact that intended use can be established through promotional claims does not preclude the possibility that other evidence may be relevant as well,” FDA said in the Federal Register notice announcing the final rule.
 
FDA also declined several comments challenging the inclusion of “design or composition” of an article as a type of evidence relevant to establishing intended use. The agency points out that it is able to consider product characteristics when determining whether a product is “intended to affect the structure or any function of the body” and therefore subject to regulation as a medical device.
 
Additionally, FDA rejected comments hinging on both the First and Fifth Amendment, asserting that it “does not believe this rulemaking implicates the First Amendment,” and refuting calls for clearly drawn lines for what communications are permissible or impermissible. “While FDA agrees that laws must give a ‘person of ordinary intelligence a reasonable opportunity to know what is prohibited,’ ‘meticulous specificity’ is not required,” the agency wrote.
 
The final rule is set to take effect on 1 September 2021.
 
Federal Register notice