Keith Christopher

Speaking Session: It’s Complicated: The FDA Regulatory Reality of Combination Products

Keith Christopher
Director

JNPMEDI

Keith Christopher, Ph.D., is Director of Regulatory Affairs at JNPMEDI Inc. in Seoul, where he advises medical device, digital health, and pharmaceutical companies on regulatory strategy and submissions for the US and Asia-Pacific markets.

Keith spent nearly six years as a reviewer at the U.S. FDA, working on both sides of the combination product divide. As a Lead Reviewer in CDRH (2020–2024), he reviewed multi-component ophthalmic surgical devices and glaucoma treatments across nearly every submission type, including 510(k)s, De Novos, IDEs, PMAs, Q-Submissions, Breakthrough Device requests, and 513(g)s. He also served as primary reviewer for combination products with drug and biologic delivery mechanisms. As a Human Factors Evaluator in CDER (2024–2026), he assessed combination products across drug and biologic submission types and helped shape policy on human factors and user interface design.