US FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the “intended use” of a product. A product’s intended use determines whether it is a medical product within the scope of FDA’s jurisdiction. This proposed rule, Amendments to Regulations Regarding “Intended Uses,” is an important step forward in fulfilling our public health mission and our promise to provide better clarity to regulated industry and other stakeholders.

The proposed revisions to the intended use regulations do not reflect a change in the FDA’s policies and practices, but rather seek to clarify the regulatory language describing the types of evidence we consider relevant to determining a product’s intended uses. The purpose of our proposal is to update our regulations to better reflect the FDA’s longstanding approach to intended use and provide greater clarity for regulated parties.

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