Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Kristina Lauritsen, PhD
Combination Product Regulatory Advisor
Product Jurisdiction and Combo Product Team
Office of Executive Programs (OEP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor and Product Jurisdiction Officer within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER’s policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA’s Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.
Abstract
This session provides an overview of the FDA’s regulatory review process for combination products, defined as medical products composed of two or more different types, such as a drug and a device. These can be configured as single entities, co-packaged kits, or cross-labeled components. The FDA determines the lead center for review (CDER, CDRH, or CBER) based on the product’s primary mode of action, emphasizing review of the product as a whole with collaboration among centers. The presentation covers relevant application types and highlights recent regulatory updates, including guidance on Prescription Drug Use Related Software (PDURS), the impact of the Genus court decision on ophthalmic product regulation, and the final guidance on Human Factors Engineering for combination products. Best practices for industry engagement are discussed, recommending sponsors identify combination product status and the lead center early, use formal feedback mechanisms like Requests for Designation (RFD) or center-specific meetings, and provide comprehensive information to the lead center, even for questions about non-lead constituent parts, to ensure effective communication and regulatory consistency.