PorzioLS EA Update: Final Rule on Intended Uses Issued by FDA

August 05, 2021

By Porzio Life Sciences

The U.S. Food and Drug Administration (FDA) issued a final rule on "Intended Uses" in the August 2, 2021, Federal Register. After multiple delays in 2017 and 2018, FDA issued a notice of proposed rulemaking in September 2020 to withdraw portions of the final rule issued on January 9, 2017 and proposed a new rule to provide more transparency regarding whether a product is intended for use as a drug or device.

The final rule, which goes into effect on September 1, amends FDA's regulations describing the types of evidence needed in determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and FDA's implementing regulations, "including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use." The final rule clarifies that a firm would not be viewed 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 healthcare providers for such use.”

As part of the final rule, the agency responds to multiple comments and provides examples of the evidence the agency considers when determining the intended use of a product. FDA also notes that the rule does not change FDA's current policies "as articulated in various guidance documents."

A copy of the Final Rule is available here.

For more information regarding FDA guidance, please see the OPDP Promotional Violations section of the Enforcement Actions Database.

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