People
McKenzie Cato's expertise is assisting medical device, pharmaceutical, and food and beverage companies with pre- and post-market regulatory topics. McKenzie helps companies in developing their FDA regulatory strategy, preparing regulatory submissions, responding to FDA requests for information and data, drafting regulatory policies and procedures, and reviewing advertising and promotional materials. McKenzie also assists companies with FDA, DOJ, and DEA enforcement matters, regulatory due diligence, and state regulatory and licensing issues.
Juris Doctor, George Washington University Law School, honors
B.S. Chemistry, Georgetown University
District of Columbia
Pennsylvania
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
Juris Doctor, George Washington University Law School, honors
B.S. Chemistry, Georgetown University
District of Columbia
Pennsylvania