Yes, the rules are hard and its even harder to go through the process of getting your product pass. However, I believe it is necessary to keep it this way so that big companies don't take advantage of the process and ruin its patients lives. The research might be delayed because of this but I personally think it is necessary to have this rules.

The FDA was organized by the U.S. as the regulatory department responsible for all human drugs, vaccines, medical devices, tissue for transplantation, equipment that emits radiation, cosmetics, animal drugs, and food. The FDA main purpose is to protect the public health and safety. In reality that is a huge responsibility to be burdened with and that is why the FDA sets such strict regulations, protocols, and standards on medical devices, vaccines, drugs, etx… Yes, from an industry prospective the FDA does slow down process on devices/drugs because of all the regulations. But from the point of view of a person in the U.S. the fact that we have a strict system in place to ensure and enforce regulation on everything that comes in contact with me and my family is almost of relief. I do believe that the FDA system is not perfect and needs work, especially since there are medical devices, drugs, cosmetics, etx.. that get recalled because of myofunctions. In conclusion, no I don’t believe that the FDA is helping speed innovation but I do believe that through the FDA industry is developing safer and stable devices, which in turn is benefiting the community more than a product that does not undergo FDA regulations.

I don't think FDA is too strict in approval the medical device or drugs. There are way too many side effects later in life which might not be visible at the time of the inventions. Checking every meticulous detail, and putting together all the pros and cons, and making decision is hardest thing ever. If something goes wrong, FDA will be the one to blame for. I get sometimes it does feel like innovations are getting slower, but better safe than sorry.

Any device that is going to be expected to help save and prolong human life should be strictly regulated. I believe people should have full confidence in anything they purchase that is expected to save their life. I also believe that more holistic medicines should be allowed to be marketed but not receive the FDA approval. I believe if a person is informed that a medicine is not approved by the FDA, and continues to desire the medication they should be allowed to do so. I also feel like a lot of the FDA regulations can be tedious and fixated on details that do not really affect the product functionality or effectiveness. When a company is forced to use an entire Engineering department just to regulate paperwork alongside a document control department then it can be detrimental to mankind. When very intelligent men and women are forced to spend their time worried about paperwork rather than the greater good the FDA seems to be more of an enemy than ally.

I personally feel the FDA is in the right for being as strict as they are. In fact, they may not be strict enough as the products that get released into the market often get recalled after further investigation. I'd say the FDA should be strict since their strictness can prevent harm to potential customers. I agree that although the FDA claims they are "advancing the public health by helping to speed innovations that make medicines more effective” they in fact make things like NDAs take years to enter the market, but for good reason. Its in a company's best interest to not get sued or have to recall items since it'll save them money and their reputation. In some way, having NDAs take years to enter market could in turn be speeding the process of medicine if you think about this way: the NDA that had countless clinical trials is approved, so researchers can take this new drug and further develop it without fear of its validity. The FDA was created because of mislabeling in the past; their regulations are here to protect the masses from otherwise negligent companies.

From my past experience working at two different medical device companies it always seems that the FDA is extremely tough and is very difficult to work with. I do think that FDA is slowing down the process by dragging out different stages of approval and testing. However, I do not think that FDA is being too strict. When it comes to medical devices, and especially implantable medical devices, they pose a serious health concern and risk for the user. If enough time is not taken to clear and allow a new medical device to the hit the market then the users can become seriously injured from the body rejecting the device or the user can die due to complications from the device that were not accounted for. I think the middle ground is the FDA allowing devices that pass for the Humanitarian Device Exemption to be used on individuals who are extremely sick and do not really have any other option but attempting to use the device or drug. In addition, when it comes to drugs such as vaccines, it is important that the device is 100% safe and effective considering it will be administered to possibly millions of individuals. It may take years to approve devices or drugs, but it is important to save lives and to make sure that the products that do make it through the process, are the best and will stay on the market for a long time. I believe in the future, devices that are not new and pose no serious risk should be advanced through the market a lot quicker, and should have fewer regulations and years of testing.

I believe that FDA is not slowing down the process of the product with all the rules and regulations that they follow. They have strict guidelines that are supposed to help make sure the product that is being made is not harmful to anyone. By them going through each step, each documentation, and making sure all the methods and procedures are followed, it makes the product less likely to have issues. Even if the product has issues in the future, everything can be traced back with the documentation and methods that were used because of how strict the FDA is. I also believe that FDA could become stricter because outside the USA, there are different drugs that are banned in those countries but not in the US. For instance, the usage of opioid painkillers is much more regulated in Japan, Europe, Germany and other countries in the UK. There are still people in those countries breaking bones and having surgery, but they are less dependent on opioid painkillers while in the US, there are more people depending on the drug. If FDA were stricter about how these drugs were used, there would be less people dependent on drugs just like how it is handled in Europe. FDA’s strictness can slow down the process but that means taking the time to work on a drug and make sure it doesn’t have any flaws. These drugs and medical devices are going into people and could be very risky, so these products must be safe for people to use. Without FDA regulations, there would be more people getting sick and injured. I believe the strictness and delays are beneficial in the long run.

FDA is the government agency that protects and promotes the public health by regulating food safety, vaccines, medical devices. FDA is strict and puts regulation on the product which to be released into the market. Before the product enters the market, the product needs to go through the FDA regulations which causes delay in the release. FDA ensures that the products are safe to use by the people and doesn’t cause any risk to the health of the people. If FDA is not strict then the companies will market the products without proper safety and regulations which may cause harm to the people. I believe that the FDA rules should be strict to make sure that the drugs and medical devices are safe for the use if the people.

Although the FDA may seem strict from the industry perspective, it is definitely appreciated as a patient! In my opinion, the FDA's job is to be strict with their regulations. As some people said before, if they become lax it could adversely affect an incredible amount of people, something that has happened in the past. From the food to the medical industry, history is filled with examples of unregulated medical practices and products harming the end-user. However, in my experience, sometimes complying with the FDA means going through steps that are irrelevant to your product. For example, I worked on a uterine device that we had to run static and cyclic tests on, even though it would never be under static conditions. In this sense, we spent time, resources and money on something that we needed to present to the FDA, but would disregard in our research. Although this is a small example, I'm sure it is extended to tests/requirements with bigger effects.
Still, I think it is better to have an overly strict regulation agency than a relaxed one that would result in unnecessary harm and create a greater deficit of time and money in the end.

I strongly believe that the FDA is too strict and rigid because of all of the regulations it imposes on healthcare in America. I understand that its mission is too improve quality and maintain innovation but imposing rules and regulations hinders the ability to innovate. Regulations are meant to insure the public against mistakes but without allowing for mistakes in research and trials prevents learning to an extent. It's very hard to innovate and produce if there are too many rules that are imposed. This is one of the reasons why big companies (e.g. Johnson&Johnson) shipped their drug manufacturing facilities to Canada and sell their products back into the United States. One particular FDA regulation that I am against is it requires that a new drug product must work and be safe to the patient. This is part of the reason why prescription drugs are expensive because the standard is so high. If pharmaceutical companies were allowed to market drug products that are safe to the consumer but may not work, prices will go down dramatically. The important thing is that the consumer is safe, even if the drug doesn't perform as expected. The FDA is too strict because there is a lot of liability involved. Furthermore, what drives up quality is competition, not regulation. Companies cannot just get away with selling defective products because if it backfires, they are going out of business. As long as there are competitors, each business will try to beat each other by improving quality and lowering costs.

I think the reason the FDA is so harsh when it comes to rules, regulations, and the process to approve a device/treatment is because of liability issues. If a patient/customer is not satisfied with the device or shows any adverse effects, it becomes a huge issue. Not only would companies lose money, but patients can also become hurt or ill as a result of devices not working properly. Also, as people have already stated before, the FDA needs to maintain a competitive market to ensure that innovation will continue. Unfortunately, the process for approval can be very long, making it very inconvenient for companies trying to create revenue off of the product; however it is important to remember that these devices are usually meant to treat illness. From the opposite perspective, I think it would be worse if the FDA had regulations that were less strict. More people would show adverse effects as a result.

I think this topic is a little complicated and your opinion will depend on which side you stand. If you work on trying to develop new products to help people, you will find that the FDA is way too strict, but if you are more on the consumer side, you will hope that they are strict as you don't want to use any product that wasn't properly regulated and so on. Personally, I understand why they have so many regulations, and perhaps we should consider that without the necessary regulations, products will be out there causing more harm than good. Although is hard on the research perspective because we want to explore new solutions, or investigate new approaches that could lead to great results, we shall not forget that the main objective is to help people and that it's better to prevent any harm.

It might be a lot of work on the companies' end because of all the regulatory steps they need to follow to bring a product to the market. It seems to be tedious work but these products are used on or implanted into humans and in order to protect their safety, FDA has to be strict about its rules and regulations. It does slow down the process of products coming to the market but I think it is much better to bring something out late with a lot of caution than to bring something out without proper testing and documents that will harm people and possibly result in a lot of lawsuits for both the companies and the FDA.

The balance between safety and speed through the system is something that is hard to balance, and whilst I think the process takes too long I would much rather a system that takes longer but makes sure that the products that are released are safe, rather than have a system where things can get cleared faster but might be unsafe.

There are other factors that are major downsides too. The elongated approval time means that only companies that can sustain themselves with other income sources whilst products are being approved are able to get products through. This leads to only large companies being able to do it which can cause stagnation in terms of innovation. I also think this creates a different mentality within the industry. Many startups know the only way that they can get their product to market is to either have angle investors willing to gamble on the company or to get bought out by a larger company.

I don't think the balance it right currently but I don't know if there are any changes that can be made that will decrease approval time without putting the consumer in danger.

In my views FDA has to be strict to ensure the good quality of the products that are launched in market as they are related to someones life. Yes FDA takes too long for approval sometimes But if FDA would simplify the process and take less time than there would be more products and lessening time might cause problem in safety.According to me FDA are great in their job its just it has to make some simplicity in precess for the advantage of manufacturer and people. We should also consider that FDA makes that product go through lots of trials that are time consuming and are benefit of people. It is for our benefit and prevention of hazards and save lives.