regulatory affairs is complicated. FDA has many branches. CDRH, CBER, CDER. One regulated medical devices, biological, and drug compound. Depending on the type of drug/device and risk classification, will dictate time for approval. A simple medical device like class I may not need any approval. A complex device like class III is 4-7 years. Biological is 4-7 too. Drugs can take 7-15 years. Not all approval timeline is the same.