Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements to harmonization of product classifications — at the 2023 Combination Products Summit held by the AFDO/RAPS Healthcare Products Collaborative.
The following is an excerpt from the “fireside chat” moderated by Susan Neadle, principal consultant and president of Combination Products Consulting, and several FDA experts from the Office of Combination Products (OCP), the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). The discussion has been edited for length and clarity.
UDI requirements
Neadle: Can you comment on the unique device identifier (UDI) requirements for combination products? Specifically, what parts of a co-packaged product need to be serialized? Is it the drug and the device?…
