Understanding whether a magnetically guided drug-delivery nanorobot is classified as a drug, device, or combination product under 21 CFR Part 3.
Under FDA regulations, a product comprising a medical device (magnetic guidance system) and a pharmacological drug (chemotherapy payload) is classified based on its Primary Mode of Action (PMOA).
If the primary therapeutic effect is achieved chemically, FDA CDER takes the lead with CDRH consulting on device safety, requiring both Investigational New Drug (IND) and device design controls.
Sponsors must rigorously characterize particle size distribution, zeta potential, endotoxin contamination, and batch-to-batch reproducibility using standardized assays defined by the Nanotechnology Characterization Laboratory (NCL).