February 5, 2018
“Combination products present significant opportunities for improvement in patient care – consider digital pills, such as medicines with an internal sensor that when ingested, sends a message to a wearable patch, and then transmits the information to a mobile application so patients and physicians can monitor and manage treatment. Because combination products often combine a drug or biologic with a device, these products can sometimes be more complex to develop—and it can be less clear to innovators on how to best engage the regulatory process to advance these innovations. For example, potential differences in the premarket review pathways across medical product centers can impact the regulatory processes and timelines for development. We're focused on implementing an efficient framework to ensure the timely and effective review of combination products to create the most robust pathway to advance these kinds of innovations. We’re seeing innovations that hold out great promise, but they’re increasingly blurring the lines across our medical product centers. We believe cross-center collaboration is key to successfully advancing safe and effective combination products,” said FDA Commissioner Scott Gottlieb, M.D. “Today, as part of several steps we’re taking in this area, we’re announcing a framework designed to enhance clarity, predictability, efficiency and consistency of premarket review for combination products. This framework will help ensure that the FDA coordinates effectively around the premarket review of these products. Among other steps, we’re clarifying what pathways to approval are available depending on whether a combination product is drug-led, biologic-led or device-led. We’re seeking feedback on this proposed approach and we’ll also be publishing additional guidance on specific premarket considerations for combination products to ensure efficient product development.”
Combination products are medical products that combine a drug, device and/or biological product. The lead center in the regulation of a combination product is determined based on which part of the product contributes most to its intended effects – in other words, provides the “primary mode of action.”
Today, the U.S. Food and Drug Administration issued draft guidance for industry, Principles of Premarket Pathways for Combination Products. The guidance presents the current thinking of the FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate, including new drug applications or abbreviated new drug applications for drug-led combination products; stand-alone or biosimilar biologics license applications for biologic-led combination products, and 510(k), De Novo or premarket approval applications for device-led combination products.
In order to ensure efficient review, a single application is generally appropriate for combination products. As these innovative products combine a drug, device and/or biologic, cross-center collaboration is key. The FDA will apply a consistent, risk-based approach to address regulatory questions, including scientific questions, utilizing relevant expertise from the lead and consulted centers. The framework outlines this collaborative model that the FDA will pursue.
The FDA is publishing this draft guidance as part of its efforts to implement the 21st Century Cures Act and in keeping with the agency’s long-standing commitment to transparency, efficiency and regulatory consistency in facilitating development of safe and effective combination products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. FDA also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.