FDA Moves to Delay Effective Date of “Intended use” Rule for Medical Products

The US Food and Drug Administration released a press release announcing the proposed delay for an effective date in a final rule set to take effect March 19, 2018. The FDA is seeking comments on the proposed rule by February 5, 2018. The final rule was published in the Federal Register January 9, 2017 and saw continued delays to seek public opinion. The rule deals with amending existing FDA regulations which determine what evidence can be considered when defining the ‘intended use’ of a medical product. [1]

The original rule “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’” was set to go into effect on February 8, 2017 and was designed to “clarify the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination product under the Federal Food, Drug and Cosmetic Act (FD&C Act).” The convoluted history of this rule begins with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) which modified the FD&C to allow the FDA to regulate tobacco products. This, however, did not include tobacco products that are a drug, device or combination product. The rule was put into effect to clarify the definition of a tobacco product regulated by the FDA and products falling under a drug, device or combination product. It also sought to clarify the intended uses and what may be used as supporting evidence for the intended use of a medical product.[2]

The rule met with some uncertainty and the effective date was delayed seeking comments from the public. The main part of the rule, concerning tobacco, was not under discretion and was put into effect – the portion addressing intended use and what evidence the FDA could use to determine a medical product's intended use met great uncertainty and concern from the public. The issue rests on “how manufacturers communicate about and promote their products.” [3] The rule unwittingly (or maybe not since the new language on intended use that was included in the final rule was not in the proposed rule) touched on a crucial role that the FDA plays in determining the intended use of a product. 

The rule allows the FDA to consider “any…relevant source” in determining a product’s intended use including the product’s labeling, promotional claims and advertising. The determination can be made off of direct and circumstantial evidence and the FDA is not bound by the manufacturer or distributor’s claims. 

The FDA has asked that people submit comments on or before February 5, 2018. Let your voice be heard by contacting the agency at https://www.regulations.gov.

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[1] https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

[2] https://www.federalregister.gov/documents/2017/01/09/2016-31950/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

[3] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592358.htm

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