PMOA Proposed Rule:
May 7, 2004 Federal Register
"Mode of Action" would be defined as the means by which a product achieves a therapeutic effect
"Therapeutic" includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body
Three types of modes of action: biological product, device, drug
Combination products are comprised of more than one type of regulated article [or constituent part] and will typically have more than one identifiable mode of action (e.g., drug and device, device and biological product, etc.)