This piece was published online in Regulatory Focus, a RAPS publication, in July 2023. It is available to download via the link at right. RAPS members may also read the article on the RAPS website.
When a device is intended for use with an already approved drug in a manner that is not consistent with the drug’s approved labeling, regulatory challenges frequently emerge in determining whether the drug labeling must be changed to reflect its use with the device. This article highlights some of the unique regulatory considerations associated with cross-labeled combination products, particularly devices referencing drugs, in anticipation of an expected U.S. Food and Drug Administration (FDA) guidance document this year.
Kramer M, Hilscher S. Cross-labeled combination products: A regulatory conundrum awaiting a solution. Regulatory Focus. Published online 31 July 2023. https://www.raps.org/news-and-articles/news-articles/2023/7/cross-labeled-combination-products