I've been through several *device* approvals (or rather, clearances) with FDA. FDA's primary charge is safety, so they default to being conservative on the preclinical and clinical data they want before letting products hit the market. They charge user fees and others to companies applying, in addition to their demands of data that can cost $100k's for the most simple products, to $10m's on the high end. These costs come after years of product development, where many products in the pipeline fail due to not working or risk of not making it past the FDA.
The typical FDA review group is a manager (who will be working for a Pharma company in 3-5 years), an experienced reviewer who is a lifer and satisfied with being a career federal employee, and 3 or 4 eager and inquisitive young scientists fresh out of grad school with little perspective on industry or how their tangential questions result in major $$$ to the applicant company. It's very challenging for new, smaller companies with limited money and resources to break through. This hampers innovation and competition. It's also why big dogs have hundreds of employees in the regulatory department to strategize and try to streamline the process and minimize time and cost to get to market.
What level of safety risk is the American public willing to accept if we direct the FDA to be more lenient (and less expensive) on approvals? Other countries benefit from USA innovation in drugs and medical devices. FDA approval/clearance (or the data you acquired to get it) gets you 90+% there towards approval in foreign countries. American patients pay for the innovation and FDA approval costs through higher prices than are paid elsewhere. We can cap prices or profits, but there will be undesirable effects. There are a lot of levers to pull that impact expensive healthcare is in America (pharma/device company profits, insurance company profits, FDA regulation, physician costs, medical school costs, etc. etc.). I stepped on a couple Surly doctors' toes in an earlier post that suggested physicians' income and fees were one of those levers.