Drug Device Combination Products
                     Drug Device Combination Products
Operon Strategist
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:
1. “Single entity” combination products, such as prefilled drug delivery systems.
2. “Co-packaged” combination products, such as surgical trays that include both surgical instruments 
and antimicrobial swabs.
3. “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.
Operon Strategist
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