How do you determine the correct FDA submission for combination products? What IS a combination product?
A combination product is one that combines one or more different products, as defined in the image below.
This can get complicated, because medical devices, drugs and biologics all fall under different regulatory umbrellas.
And just as with a lot of major corporations, the different FDA departments don’t often talk to each other, never mind collaborate on something, so trying to get them to work together on a submission is a very tough task.
The FDA assigns oversight of combination products based on their primary mode of action (PMOA), which in layman’s terms means the most important therapeutic action of the combined products.
A drug-eluting stent is a device, because the primary action is the opening of blocked arteries; the secondary action is delivery of drugs to prevent inflammation and restenosis. This device would be submitted to CDRH (Center for Devices and Radiological Health).
A drug-eluting disk would be considered a drug, because it was designed to deliver chemotherapy for brain tumors, even though it can also be used as a device to deliver drugs more locally. The disk would be submitted to CDER (Center for Drug Evaluation and Research).
A wound dressing with a collagen matrix that is intended to be used as a skin substitute would be considered a biologic, and submitted to the CBER (Center for Biologics Evaluation and Rsearch). A simple wound dressing with a collagen matrix for use in moist environments would be submitted to CDRH.
These are just a few examples, but you can see why choosing the right FDA submission for your combination products can be less obvious than you may have thought.
Check out the original LinkedIn post: https://www.linkedin.com/posts/michellelottraqa_medicaldevices-fda-compliance-activity-6764965614671937536-V8kV
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