USA – An assessment of the proposed rule to change US FDA’s interpretation of Intended Use

The US Food and Drug Administration published a proposed rule in September 2020 to update the language used to define intended use in relationship to both medical devices and drugs. This should be carefully reviewed by manufacturers, and action is recommended.

Overview of Intended Use

Traditionally, the intended use of a medical device or drug has been considered the general purpose of the product or its function, including the relevant medical disease or condition for which the product is intended to be used, and has been evaluated by FDA through the review of proposed labeling for products which require a premarket submission…