FDA clarifies "Intended Use"

The U.S. FDA revised the text of their "intended use regulation" to provide additional examples and explanations.

In particular clarity is provided by describing examples of types of evidence the agency would consider relevant to determining the intended use of a product.

Examples of types of evidence

Types of evidence relevant to establishing the intended use are:

  • Labeling claims and representations, advertising matter, and oral or written statements by persons responsible for the labeling, or their representatives,
  • Claims or statements made by or on behalf of a firm that implicitly represent a product for a particular use (implied claims),
  • The characteristics of the product and its design,
  • Circumstances surrounding the distribution of the product and the context in which it is sold.

According to the agency, a firm will not be regarded as intending an unapproved use of an approved product based solely on that firm's knowledge that the product is being prescribed or used by health care providers for such use (e.g. social media messages that are not commented or otherwise endorsed by the firm´s account).

The Agency says that any final rule based on this proposed rule will become effective in the next 30 days.

For more information please see FDA´s Regulations Regarding “Intended Uses”.

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