PURPOSE: This workshop will focus on defining patient experience data (PED) as described by the 21st Century Cures Act, how the FDA Reauthorization Act of 2017 (FDARA) supports the science of patient input, and what this data could look like when submitted to the FDA. Workshop participants will have the opportunity to discuss these topics and study considerations. DESCRIPTION: Over the past five years, the FDA has made strides in incorporating the patient voice in medical product decision-making. The Patient-Focused Drug Development and Patient Preference initiatives, begun under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, led to 24 public meetings to learn from patients about their disease experience and a guidance document about patient preference information in medical device applications. This momentum has now been solidified in the 21st Century Cures Act with the continuation of Patient-Focused Drug Development and the new FDA initiative to acknowledge PED included in medical product submissions. FDARA supports capacity-building and public meetings to discuss approaches for incorporating patient input in medical product submissions. The FDA is developing a series of guidances on how to incorporate the patient’s voice in medical product development and decision-making. But what is PED? This workshop will give participants an opportunity to discuss this topic and hear the perspectives of FDA’s three medical product centers. This workshop will inform participants about a) how FDA has been evolving in capturing the patient’s voice; b) how PED is defined in the regulatory setting; c) considerations when designing studies to collect PED and, d) using PED throughout the medical product lifecycle. Discussion leaders will represent CDER, CDRH, and CBER and will engage participants in a conversation about challenges to collecting PED and how different types of PED may be appropriate for answering different types of regulatory questions.