The necessary regulation to get FDA approval of a combination product is first the company has to request for designation (RFD), in which companies have to outline the rationale of the product. Then, the company has to submit the “pre”pre-investigational device exemption(“Pre”pre-IDE) and the pre-IDE are regulatory meeting. The pre”pre-investigational device exemption is a not a real documented official procedure; it is just when the company calls up the FDA to ask a question regarding their research and the way they set up the clinical experiments. Pre-IDE is a document that proposes pre-clinical research necessary in order to start the human trial. The next step is the IDE which is written by the clinical research and the regulatory guides give a pathway required by the FDA to precisely present the data. The last step is the premarket notification or the 510(k), which must demonstrate if a device has “substantial equivalence” to a “predicate device”.

A. The CDER’s steps of regulation is (1) IND, (2) Phase 1,2,3 and NDA
B. CBER’s step of regulation is (1) IND, (2) Phase 1,2,3 or the pivotal trials (3) BLA
C. CDRH’s steps of regulations for class 1,2 is just the 510 (k); for class 3: it goes through IDE, pivotal trials, PMA