Yu-Chieh Chiu

Dr Yu-Chieh Chiu is an assistant director at the FDA's Center for Devices and Radiological Health (CDRH). Joining the agency in 2016, he has served in CDRH/OPEQ/OHT4 since August 2023. Dr Chiu oversees medical device reviews with a focus on wound care products, having reviewed and signed off on over 500 premarket and postmarket submissions while leading the development of wound device guidance documents and participating in interagency projects. He serves as the Wound Care Collaborative Community liaison, where he contributes his expertise to advance wound care device regulation and foster cross-functional collaboration across stakeholders. His roles at FDA have included Team Lead for OHT1/THT1A2 (October 2021 - August 2023) and Lead Reviewer for OHT4/TH4B4 (January 2018 - October 2021), as well as several acting leadership positions across different offices. 

Throughout his FDA career, Dr Chiu has reviewed over 700 submissions across diverse device categories, including wound care devices, plastic surgery devices (dermal fillers and microneedling devices), ophthalmic devices (contact lenses and dry eye devices), and orthopedic devices. He is recognized as a biocompatibility expert across CDRH, providing consultation on biocompatibility issues for various device types and training reviewers to conduct independent assessments. Dr Chiu has contributed to regulatory policy development, leading the drafting of negative pressure wound therapy guidance and participating in FRO preamble preparation/finalization, while also serving as a technical expert for ASTM F04.43 Cells and Tissue Engineering Constructs. Dr Chiu is knowledgeable about FDA regulations, including the FD&C Act, 21st Century Cures Act, and device-specific guidance documents. His combination of scientific expertise, regulatory knowledge, and proven leadership in supervising review teams and mentoring staff has made him an invaluable contributor to FDA's mission of protecting public health through effective medical device regulation.