McKenzie Cato

McKenzie Cato advises medical device, pharmaceutical, food and beverage, and other life sciences companies on complex FDA regulatory matters throughout the product lifecycle. Her practice encompasses regulatory strategy and product development, premarket submissions and interactions with FDA, labeling and promotion, and postmarket regulatory compliance. She helps clients navigate novel regulatory questions, assess regulatory risk, and develop practical strategies that account for both regulatory requirements and business objectives.

She has significant experience with medical device and combination product regulatory matters, including product classification and regulatory pathways, premarket development and submissions, clinical investigations, and interactions with FDA. Her practice also encompasses evolving regulatory frameworks for artificial intelligence and machine learning, software and digital health technologies, and in vitro diagnostics.

McKenzie also counsels food and beverage companies on product formulation and ingredients, labeling and promotion, and other federal and state regulatory requirements, including conducting regulatory risk assessments and identifying practical paths forward for novel ingredients, product claims, and other compliance issues.

In addition, she represents companies in FDA, DOJ, and DEA enforcement matters and advises on regulatory due diligence, state licensing requirements, and regulatory issues arising in transactions and commercial operations.