Cortez Mcberry

Cortez McBerry, PhD is a Partner with NDA Partners and served as Regulatory Consulting Director with the company since 2021. He was formerly a Lead Reviewer in the FDA Division of Immunology and Hematology Devices in the Office of In Vitro Diagnostics (CDRH), where he was responsible for reviewing De Novo requests, PMAs and 510(k) applications for in vitro diagnostic products, reviewing companion diagnostics in IND/BLA applications and in vitro diagnostics in drug/therapeutic labels, conducting meetings with industry, and developing regulatory strategies and policies. He is experienced in regulatory strategy, regulatory affairs, labeling, and managing US, EU, and Notified Body regulatory submissions for medical devices and in vitro and companion diagnostics.