The FDA operates under established rules which serve as protective measures and also create restrictive barriers. On one side, they are essential for protecting patients by ensuring that unsafe or ineffective products don’t make it to the market. The history shows that dangerous drugs and devices can reach the market when safety protocols fail to exist which leads to major adverse effects. The same rules which protect patients can also create delays in the approval process which prevents patients from getting the innovative treatments they require.
The FDA maintains appropriate strictness but the main problem arises from the need for system flexibility. The FDA operates Breakthrough Device Designation and Fast Track as two separate programs which speed up innovation through safety-focused procedures. The solution to finding middle ground involves expanding adaptive pathways which enable high-risk medical devices and drugs to undergo strict evaluation but allow lower-risk and iterative innovations to progress at a faster pace through the system.
Safety needs to be the top priority but this does not require halting innovation because proper risk-based regulatory approaches can enable progress.

I do not think that a middle ground is possible because there will always be people that argue for either time range and say that it is too much or too little. It also depends on the product that is attempting to get approval because just as Class I does not require much time, a Class III needs the extra care to make sure that it does not accidentally cause more harm than good. It is difficult to gauge what time is enough and if the proper effort is not placed originally, then the FDA is more likely to get sued for not taking the necessary precautions. I think for the FDA the goal is to ensure that the device that they are approving has more benefits than the possible harm it may cause, which to figure out can take time. I do not think they are hindering any growth because there are always more people to help further the research, but also there are new issues that arise, so the product may not even become useful. Also, just because someone is researching a certain concept that does not mean that there is not another lab that is not focusing on the same concept, which could be doing better work, and they could get approved later. I think it is better to provide their due diligence and ensure the product is helpful and not worry about the possible slow down. Furthermore, if there is an actual need for a certain product it is clear that the FDA will put more effort and quickly approve certain products for example the Covid vaccine, which means that when it comes down to actually ensuring human protection, they have regulations in place to ensure they are swifty complete the process.