Posted by Michael Wonder on 13 Jan 2018
Statement from FDA Commissioner on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
12 January 2018 - The FDA is committed to ensuring that we have the right policies and processes in place to fulfil our public health mission.
This includes providing clear rules to medical product manufacturers about fundamental issues such as how the FDA will determine the intended use of a medical product. We heard concerns that the FDA’s final rule to amend the agency’s existing intended use regulations – put forward a year ago in January 2017 – wasn’t clear, and we’re committed to addressing this important issue.
This new language on intended use was included in an important, and otherwise largely non-controversial final rule notice that primarily addressed when tobacco products will be regulated as medical products, and more specifically which responsibilities for the regulation of tobacco products fall within our medical product centers versus our tobacco center. The new language on intended use relates to existing regulations that describe the types of evidence the FDA may consider to determine how a manufacturer intended for its product to be used by doctors and patients. This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work. The new language on intended use that was included in the final rule was not in the proposed rule.
