Dr. Hu Yuzhi
- FDA Attorney, Sidley Austin LLP
YUZHI HU was a senior policy advisor at the U.S. Food and Drug Administration (FDA) from 2014 – 2022. As a pharmacist and epidemiologist by training and veteran FDA staff, Yuzhi focused on clinical trial evaluation and policy at the Center for Device and Radiological Health (CDRH). He led teams reviewing marketing application and postmarket oversight and compliance of devices in all therapeutical areas and submission types including PMA, 510(k), De Novo, HDE, PAS, and 522 mandated surveillance studies. Yuzhi led the CDRH-wide Real-World Evidence program and served as a voting member at the CDRH Policy and Process Governance Board. He was often consulted internally and externally on a wide range of subjects, including clinical trial design, data integrity, relevance, reliability, registry development, breakthrough designation, regulatory compliance strategy development, and more. Yuzhi also collaborated with and brought insights to international audiences, especially the regulators and regulated entities in China. He has provided training to FDA staff routinely regarding assessment of clinical evidence in regulatory decision-making. In addition, he drafted, trained, and implemented the following CDRH Guidances:
· Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Guidance for Industry and Food and Drug Administration Staff;
· Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; and
· Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Guidance for Industry and Food and Drug Administration Staff.
During his time at the FDA, Yuzhi received numerous awards including most recently the 2021 “CDRH Honor Award” and “FDA Excellence Award.”
Now, as a FDA attorney at Sidley Austin LLP, Yuzhi focuses his practice on various FDA regulatory, compliance, and enforcement issues. Yuzhi brings a combination of regulatory insight and scientific rigor into the complex issues that our clients face. Yuzhi helps lifescience companies, especially those with China background, navigate the intricacy of entering the US market.