Resolution to Confusion
The US Food and Drug Administration (FDA) finally finalized a rule that clarifies its position on the types of evidence it will consider when determining the intended use of a medical product. In addition, the new rule repeals and replaces the unimplemented portions of an earlier final rule on intended uses.
The FDA said that the final rule, which comes less than a year after the agency proposed it, is “largely unchanged from the proposed rule.” According to the agency, 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 rule has taken a long time to become final. The effort to update FDA’s intended use regulations started in 2015, when the agency initially issued a proposed rule that was subsequently revised and made final in January 2017, in spite of pushback from industry. Before the rule was to become effective, FDA delayed its implementation by 90 days in February 2017, then by a year in March 2017, before delaying it indefinitely in March 2018.
Confusion and concerns raised by pharmaceutical and biotech industry groups prompted the delays. They petitioned FDA to stop the rule and go back to its original proposal to delete two rarely enforced clauses, found in 21 CFR 201.128 and 801.4, that enable 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.
Last September FDA released the proposed rule, introducing new language to clarify 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,” making it clear that the firm’s knowledge of an unapproved use would not, by itself, trigger new labeling obligations. FDA also emphasized that the proposed rule reflects the agency’s interpretation of the intended use regulations and its existing policies and practices for determining a product’s intended uses.
In the final regulation, FDA nixed industry’s insistence that the agency narrow its interpretation of evidence of intended use to a firm’s promotional claims. FDA explained in the Federal Register notice announcing the final rule, “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.”
In addition, FDA declined several comments challenging the inclusion of “design or composition” of an article as a form of evidence relevant to establishing intended use. FDA said that it can consider product characteristics when determining if a product is “intended to affect the structure or any function of the body” and therefore subject to regulation as a medical device.
FDA also rejected comments hinging on both the First and Fifth Amendment, claiming 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,” according to FDA.
The final rule is set to take effect on September 1.