The FDA has placed an indefinite hold on implementing new regulations relating to how the agency determines a medical product’s intended use.
The decision to press pause on the new rules drew cheers from the medical device and pharmaceutical industries, after companies voiced their concerns last year that the proposed changes were unclear.
The FDA’s new language on intended use was meant to update the types of evidence that the agency can use to decide how a manufacturer intended for patients and doctors to use its product.
“By having clear and consistent rules appropriately grounded in public health policy that address this and related issues, the FDA is better able to maintain vigorous oversight and take enforcement actions when necessary. We need more time to consider the feedback we received and to make sure that our approach is guided by our public health mandate and to ensure the clarity of our rules on the subject,” the FDA said in a statement.
“That’s why today we proposed to delay, until further notice, the effective date of those portions of the final rule that would have revised the FDA’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended uses.”
While the FDA reviews the comments that it received for the proposed policy changes, the agency said it will revert to its existing regulations to determine the intended use of medical products.
The FDA pointed out that the new language for intended use was part of a non-controversial final rule notice that clarified when tobacco products will be regulated as medical products. To ensure that the final rule goes into effect, the FDA has decoupled the intended use language from the new tobacco rule.
“We remain committed to rulemaking on the subject of intended use, and to an open and public process regarding the substance of the rule,” the agency added. “In order to allow time to review comments received on the proposal to delay the March 19, 2018 effective date of the portion of the rule that related to intended use, and to prepare and publish a final rule effectuating the proposed delay, the agency has opened a comment period that will remain open until February 5, 2018.”
