FDA Amending Medical Product ‘Intended Use’ Regs

FDA says it intends to amend its medical product intended use regulations that describe the types of evidence relevant to determining whether a product is intended for use as a drug or medical device under the law and implementing regulations, including whether an approved or cleared medical product is intended for a new use. A Federal Register notice says the action also will repeal and replace portions of a 1/9/17 final rule that never became effective. “This action is intended to provide direction and clarity to regulated industry and other stakeholders,” the notice says.

An online statement attributed to commissioner Stephen Hahn says the revisions do not reflect a change in the agency’s policies and practices but rather seek to clarify regulatory language describing the types of evidence FDA considers relevant to determining a product’s intended uses. “The purpose of our proposal is to update our regulations to better reflect FDA’s longstanding approach to intended use and provider greater clarity for regulated parties,” he says.

The preamble to the proposed rule describes examples of types of evidence FDA says it would consider relevant in determining the intended use of a product, including a variety of direct and circumstantial evidence. It also outlines several examples of types of evidence that, standing alone, would not be determinative of intended use.

“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,” Hahn concludes. “Such clarity and consistency are critical to ensuring that parties understand their regulatory obligations and that FDA can exercise effective oversight responsibility. For this reason, this rulemaking is an important priority for FDA.”