In the regulatory world, the importance of clarity cannot be understated.
FDA recognized the importance of clarity in regulation with a recent proposal to delay the implementation of parts of a final rule put forth last year regarding the way the agency determines intended use of products, including medical devices. The rule was due to become effective March 19.
FDA said concerns had been raised that the final rule to amend its existing intended use regulations wasn't clear, and the agency said it needs more time to consider the feedback.
The new language on intended use was included in what FDA described as an important, and "otherwise largely non-controversial" final rule notice that primarily addressed when tobacco products would be regulated as medical products, and which responsibilities for the regulation of tobacco products fall within FDA's medical product centers versus its tobacco center.
The final rule described the types of evidence FDA may consider to determine how a manufacturer intended for its product to be used by doctors and patients. The new language on intended use that was in the final rule was not in the proposed rule, the agency noted.
By delaying implementation of the related portions of the final rule FDA said it is not creating a new policy, but rather reverting to its existing regulations and interpretations on determining the intended use of medical products. These are the same regulations and interpretations that have been in effect for decades, the agency said.
The tobacco-related portions of the final rule will go into effect in March as planned. As for the delayed parts of the rule, FDA is accepting comments until Feb. 5. Instructions for submitting such comments can be found here.