The US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of premarket pathways for combination products, including providing details on how the lead FDA center is determined and current thinking about cross-labeled products.
While the guidance is not binding, it provides industry participants with valuable insight into how the FDA will regulate combination drug-device products moving forward and provides some clarity on information device makers will need to submit in premarket review applications. The guidance reflects changes to the Food, Drug, and Cosmetic Act implemented in the 2016 21st Century Cures Act.
Operon Strategist as a reliable medical device consultant assists companies and medical device manufacturers by providing consulting services that support the registration of drug-device Combination Products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210/211), Device (21 CFR 820) and 21 CFR Combination Products (21 CFR Part 4). We also service clients in Saudi Arabia.
Combination Product Defined
There are three basic types of medical products: biological products, drugs, and medical devices. The laws and regulations governing each type developed at different times, although in recent years there have been significant harmonization efforts, particularly for biological products and drugs. A combination product is a product composed of two or more of these three types, such as a biological product distributed in a prefilled syringe (a biological product-device combination product) or a drug-coated cardiac stent (a drug-device combination product). Appropriate regulation for combination products must address safety and effectiveness issues for both components.
The term “combination product” encompasses many types of products, including:
- “Single entity” combination products, such as prefilled drug delivery systems.
- “Co-packaged” combination products, such as surgical trays that include both surgical instruments and antimicrobial swabs.
- “Cross-labeled” combination products, which are separately packaged products intended for use only in combination with other specified products, such as photosensitizing drugs and activating light sources.
Takeaways
Combination products continue to be a priority area for innovation in the biopharmaceutical, medical device, and digital health sectors. The final guidance is an important step towards greater clarity around how FDA conducts premarket review of combination products. As with all FDA guidance, FDA accepts comments at any time which, for this final guidance, enables stakeholders to provide feedback to FDA as it continues to shape its policies on combination products.
The final guidance also relates in part to the U.S. Court of Appeals for the District of Columbia Circuit’s April 2021 decision in Genus Medical Technologies, LLC v. FDA, which held that any product meeting the definition of both a drug and device must be regulated as a device. FDA intends to publish a notice in the Federal Register with a list of approved drugs that will transition to device status, although some have argued that Genus does not give FDA the authority to reclassify existing products. FDA intends to solicit comments before the list is finalized.
Final rule on premarket pathways for combination products
Combination product manufacturers should take note that final guidance from the US Food and Drug Administration, Principles of Premarket Pathways for Combination Products, has been issued. The rule describes combination products and how the FDA works with the applicable lead center to review premarket submissions and regulate these medical components. The report offers options for pathway selection based upon the product’s primary mode of action (PMOA) and information on how to select the most appropriate type of premarket submission process for your combination product type.
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