BIO

Director of Compliance and Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)

FDA

Keisha Thomas is the Associate Director for Compliance and Quality in FDA’s Center for Devices and Radiological Health. She provides strategic oversight, coordination and guidance over medical device quality, compliance, and enforcement efforts. Ms. Thomas is a coauthor of the recently published amendment to 21 CFR 820, “Quality Management System Regulation (QMSR)”—incorporating the requirements of ISO 13485:2016; and is spearheading CDRH’s implementation efforts for the proposed regulation. She has been at CDRH for 22 years and has an extensive regulatory, compliance, and enforcement background. Ms. Thomas has held multiple positions in CDRH, including Deputy Office Director for OPEQ/OHT1, Deputy Director for the Division of Premarket and Labeling Compliance, and Deputy Director for the Division of Enforcement A, and Quality System Team Lead in the former Office of Compliance, CDRH.