Jan 17, 2018


  • US FDA has indefinitely delayed new requirements for evidence used to determine intended use.
  • The intended use-related requirements are part of a larger final rule covering tobacco products that fall under US medical device regulations.
  • The other parts of the final rule will go into effect in March 2018.

US FDA delays medical device intended use requirements 2018US medical device regulators at the Food and Drug Administration has indefinitely delayed implementation of part of a final rule covering intended use determinations by the agency following industry questions and concerns.

The delayed requirement pertains to which types of evidence FDA may consider in order to determine a medical device’s intended use. The requirement had been set to come into full effect in March 2018 as part of a larger final rule concerning regulation of some tobacco products as medical devices.

Industry concerns over scope, Constitutionality of intended use evidence rule

Upon publication of the FDA final rule in early 2017, some industry stakeholders argued that the rule established too broad a scope of evidence types for use in intended use decisions, and that such evidence should be narrowed to include only promotional and external product claims.

Other stakeholders argued that the rule may violate US Constitutional Amendments as well as other laws and legal precedents.

In response to these concerns, FDA has now indefinitely suspended the final rule’s intended use requirements in order to consider whether to amend or rescind them, but the other sections of the final rule will still come into force March 19, 2018.

Additional US FDA regulatory resources from Emergo:


  • Stewart Eisenhart