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. 

One of the FDA's main challenges, in my opinion, is striking a balance between safety and innovation. On the one hand, the stringent regulatory procedure guarantees that goods, including medications and medical equipment, are extensively evaluated prior to being made available to the general population. This is crucial because without it, dangerous or inefficient items could cause widespread harm to humans. However, it's also true that this procedure can occasionally impede innovation, particularly for smaller businesses that might lack the means to deal with such a drawn-out and costly approval process. The middle ground, in my opinion, would entail increasing initiatives like the FDA's "Breakthrough Devices Program," which aids in accelerating high-priority technologies or simplifying specific procedures, such as improving the effectiveness of early-stage clinical studies. The true query is: how can we design a system that upholds strict safety regulations while simultaneously promoting innovation to prevent needless delays in life-saving technologies? Is speed always more important than safety, or is there a better way to strike a balance?

This is a really thought provoking question. I personally think that the FDA has to be strict to some extent to actually determine if a product is safe for consumers or not. The main purpose of the FDA is to protect consumers to introducing them to products that are user friendly. I think the FDA is supposed to be as strict as they are when it comes to marking products as safe or not. If you as a consumer want something that is safe and easy to use, wouldn't you also want them to make sure it is as safe as they can make it? That's how I see it personally. If they're not strict enough, what would you expect then? Would you expect a product that is not properly tested for human safety or something that you think would compromise your health? That's why I think they should be strict when it comes to these things because you want the best out of a product and a big part of that is that it's user friendly and safe. 

When talking about the FDA, they have certain rules in place to reduce the amount poorly designed product to enter the market. Some of these devices can help to support life or keep someone alive, so since this is the case they want to make sure that the product entering the market will do what it says and will preform under the condition it may experience without little to no failure. Most companies are in this business to make as much money as possible without some regard for the product. The FDA can turn around to help make rules to make the product meet standard and pay for repercussion if these standards are not met which could result in disaster. I feel as is the FDA is not too strict or rigid and have the rules that it does in place for a reason to help the consumer get a product that will work as intended with little to no repercussions.