CPC Pens Proposed Considerations for FDA Guidance on Cross-Labeled Combination Products and “Combined Use”

The CPC has provided this document to inform potential guidance on cross-labeled combination products and “combined use,” noting that this has not been agreed to by FDA, but we hope can facilitate future discussions on the topic. Contents include background on the topic, impact on industry, request for guidance and considerations (defining cross-labeled combination products, regulatory requirements for such products, and defining “combined use”), and examples of cross-labeling and combined use.