USA – FDA clarifies evidence for determining intended use

After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types of evidence it will consider when determining a product’s intended use. The new rule would also repeal and replace the unimplemented portions of the earlier final rule.
The saga to update FDA’s intended use regulations began in 2015, when the agency first issued a proposed rule that was eventually revised and made final in January 2017, despite pushback from industry. However, before the rule took effect, FDA delayed its implementation by a month-and-a-half in February 2017, then by a year in March 2017, before delaying it indefinitely in March 2018.
RELATED: How an FDA proposed rule for tobacco products could have a big impact on ‘intended uses’ for devices, drugsRegulatory Focus 19 October 2015; Industry groups petition FDA over revisions to ‘intended use’ ruleRegulatory Focus 16 February 2016; FDA delays final rule on intended usesRegulatory Focus 17 March 2017;  FDA delays implementing parts of ‘intended use’ ruleRegulatory Focus 15 March 2018).
The delays were prompted by confusion and concerns raised by pharmaceutical and biotech industry groups, who petitioned the agency to stay the rule and revert to its original proposal to delete two rarely enforced clauses, found in 21 CFR 201.128 and 801.4, that allow FDA to regulate products according to their actual uses based on whether a manufacturer “knows, or has knowledge of” information that would indicate that a drug or device will be used for other uses outside the product’s specified intended use…