This week’s lecture introduced us to the different branches of the FDA that new products in development get assigned. The branches in question are the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER). We also learned about combination products and depending on the product’s primary mode of action (PMOA) which branch it will be assigned to, which could be difficult in some cases where any of the three branches could technically apply. I’m sure we all have seen products and thought of which branch it was assigned to, only to find it was actually classified into another. So give an example of a combination product that is on the market or in development that you’ve seen somewhere, used, or just heard of and justify why which particular branch was assigned to it. Maybe also add in other details like what class it was assigned (1, 2, or 3) and other details

Example:
Polymethylmethacrylate (PMMA) bone cement with antibiotics
Class 2 Classification with 510(k)
Branch: CDER
The bone cement primary is used in implant fixation. It acts a void filler that creates a tight space which holds implants against the bone and acts as a plaster. Even though it has antibiotics on it, the PMOA is to act as a plaster to anchor together artificial joints to the bone.

Links:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=4525
https://www.fda.gov/MedicalDevices/ucm072795.htm#intro