Joshua Yao

Prior to joining Hogan Lovells, Joshua served as a biomedical engineer and lead regulatory reviewer at the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), where he evaluated various pre-market submissions in the respiratory technologies landscape, including Premarket Approval (PMA) applications, Investigational Device Exemption (IDE) applications, 510(k) Notifications, 513(g) Requests for Information, Breakthrough Designation Requests, and more. Joshua capitalizes off his valuable insights on FDA’s internal review policies and nuances to help clients optimize entry-to-market timelines.

Joshua was also a duly accredited FDA investigator working closely with the CDRH Office of Regulatory Affairs (ORA) as a Ventilator Subject Matter Expert. He performed on-site manufacturer inspections of Quality Systems Regulations (QSR) compliance, classified high-profile Class 1 medical device recalls, and provided technical review of the adequacy and feasibility of risk mitigation strategies. Joshua offers a first-hand understanding of FDA’s perspectives on post-market regulation when assisting clients with compliance strategy.

Joshua completed his Bachelor of Science and his Master of Science, both in biomedical engineering, at Tulane University, where he published cross-cutting research in pulmonary health and computational quantification ventilator-induced lung injury.