FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices


The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

The intended-use doctrine states that manufacturers must develop products that are reasonably safe for their intended use. FDA regulations define intended use as “the objective intent of the persons legally responsible for the labeling of [the pharmaceutical product or medical device].”

Under the old “intended use” rules for drugs and devices, the FDA indicated that manufacturers must “include adequate labeling” for unapproved uses that the manufacturer may know the product is being used for.

In particular, concern was expressed that a manufacturer’s knowledge of an unapproved use of its product might trigger requirements for new labeling, which in turn could render its distribution of a product unlawful without a supplement.

Originally, the FDA proposed deleting the knowledge-based labeling directive. However, in a 2017 amended final rule that never went into effect and that the public did not comment on (83 FR 2193 at 2217), the FDA instead proposed a rule requiring that manufacturers include adequate labeling for unapproved uses “if the totality of the evidence establishes the manufacturer objectively intends that [their drug or device] be used for an unapproved use.” Shortly after the proposal, organizations filed petitions raising concerns (i) that public comment was not allowed on the amendment and (ii) with the proposed evidence standard. Organizations requested a stay of the rule’s effective date. As a result, the FDA stayed the 2017 rule.

Under the final rule, two important changes to the regulations will occur:

  • First, the FDA will delete the part of the regulations stating that manufacturers must “include adequate labeling” for unapproved uses it merely knows about, as originally proposed in 2015. Manufacturers will not need to provide labeling for unapproved uses unless the manufacturer is regarded as intending the product to be used for unapproved uses.
  • Second, the FDA provides clarification that “intended use” is determined by looking to “any relevant source” of evidence, including direct and circumstantial evidence surrounding the manufacture and sale of a product, rather than the “totality of the evidence” approach proposed in 2017.

The final rule also “modifies the codified language of the intended use regulation for medical devices to clarify its applicability to devices that are approved, cleared, granted marketing authorization, or exempted from premarket notification.”

In its comments about the benefits of these changes, the FDA said the final rule should “resolve questions about whether manufacturers need to think about developing an action plan or strategy related to a potential new intended use of their medical products that are approved, cleared, granted marketing authorization, or exempted from premarket notification simply because a manufacturer has knowledge of unapproved uses of these products by third parties.” The FDA also commented that it did not expect the new rules to impose any significant additional costs on manufacturers.

The final rule reflects the FDA’s focus on clarifying the meaning of “intended use.” Though more developments may come, the new rule is a relief for manufacturers in the pharmaceutical products and medical device spaces.

Faegre Drinker’s life sciences industry group is monitoring implementation of the final rule and will provide any necessary updates.

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About the Author: Mary E. Hershewe

Mary Hershewe is a Products Liability Associate residing in our Denver, Colorado, office. Mary works on state, federal and multidistrict litigations with a focus on products liability, consumer protection, commercial, and health and sciences litigation. She also specializes in defending major pharmaceutical and medical device companies against claims involving allegations of strict liability, negligence, failure-to-warn or consumer protection act violations.

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