As per Red bar, Shori, there is a big difference between medical...

As per Red bar, Shori, there is a big difference between medical device and drug approvals.

PMA approvals (for more risky devices) take around 262 days on average with an approval rate over 90%. 501(k) approvals (for less risky devices such as GMed's) take only 95 days on average with an 85% success rate (https://www.meddeviceonline.com/doc/fda-s-pma-approval-rate-soars-to-year-high-0001).

The process for drug approvals is much more complicated. A useful resource is a large recent study of drug approvals (https://www.bio.org/press-release/bio-releases-largest-study-ever-clinical-development-success-rates). There is a link in this article to the underlying paper which is worth a read. Basically around 85% of submissions to the FDA are approved. However this is only after a very long process of clinical trials. Most drugs fail to pass all of these trials to make it to FDA submission. Only around 10% of drugs made it from pre-clincial to approval. Most drugs fail at Phase II. That is, it seems reasonably easy to find a drug that will kill a disease in a test tube and is not (too) toxic to humans (Phase I), but is is very hard to show that the drug kills the same disease in humans (Phase II). Around 70% of drugs fail to move from Phase II to Phase III trials.

In terms of timeframe, it takes around 10 years to go from test tube to FDA approval for a drug. Most of that time is taken up by the clinical trials which need to be conducted before submission to the FDA for approval.