Rachana Visaria

Dr Rachana Visaria is the Acting Director of the Division of Plastic and Reconstructive Surgery Devices within the Office of Surgical and Infection Control Devices (OHT4) at the FDA's Center for Devices and Radiological Health (CDRH). She holds a PhD in Bioengineering and is a Regulatory Affairs Certified (RAC) professional with over 10 years of experience in regulatory science, policy development, and total product lifecycle (TPLC) oversight. Her regulatory expertise spans diagnostic, monitoring, screening, and therapeutic products, including wound care devices, surgical implants, respiratory devices, digital health technologies, and neurostimulators. She has directed the review and evaluation of complex regulatory submissions including PMAs, De Novos, breakthrough device designations, and Medical Device Development Tool (MDDT) requests. She has authored numerous peer-reviewed publications and book chapters, including recent work on digital health regulation, and serves as FDA's primary liaison to several international standards working groups. Her commitment to regulatory excellence, stakeholder collaboration, and patient-centered innovation has been recognized through multiple CDRH awards.