FDA proposes updates to clarify evidence related to '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.

FDA's longstanding position is that, in evaluating a product's intended use, any relevant source of evidence may be considered. This longstanding position remains unchanged in the regulations being proposed today. However, the proposed revisions clarify an important point: that a firm's knowledge that a health care provider has prescribed or used an approved or cleared medical product for an unapproved use, standing alone, is not sufficient to establish the product's intended use. We believe that this update will provide greater certainty and predictability for regulated parties.

In the preamble to the proposed rule, we provide additional clarity by describing examples of types of evidence we would consider relevant to determining the intended use of a product, including a variety of direct and circumstantial evidence. The preamble also outlines several examples of types of evidence that, standing alone, would not be determinative of intended use. We believe these examples will help regulated parties to navigate common scenarios with greater certainty.

In recent years, we have worked to revise certain language that is currently included in our intended use regulations and that does not accurately reflect current FDA policies. In 2015, we issued a proposed rule that, among other things, would have revised that language. The agency considered the feedback and support we received on the proposed rule and made additional changes when we published the 2017 final rule.

In light of questions and concerns that arose from the changes made in the final rule, FDA decided to delay the effective date of the relevant portion of that 2017 final rule until further notice, to allow for additional consideration of the substantive issues raised in the public comments we received related to the final rule.

Since then, we have considered the issues raised by the 2017 final rule, including feedback and input from regulated industry and other stakeholders, and we are now proposing to repeal and replace the intended use portion of the 2017 final rule. We received many useful comments that assisted in our policy development. Public comment is an important part of the rulemaking process that can inform and influence the agency on critical regulatory matters. We look forward to receiving input on today's proposed rule.

We believe that by revising the text of our intended use regulations to better reflect our longstanding practice, and by providing additional examples and explanation in the preamble, we will give clarity to stakeholders and enhance consistency in our regulatory approach. Such clarity and consistency are critical to ensuring that parties understand their regulatory obligations and that the FDA can exercise effective oversight responsibility. For this reason, this rulemaking is an important priority for the FDA.

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