I believe the FDA is doing the right thing and is not being strict at all as it is there to assure that we ,the public, is safe  and there is safety and efficacy in all the products it regulates. The FDA follows the rules and regulations that are necessary and formed for the best of everyone's interest. Having an intervention from any government department should not be entertained as this might lead to companies always finding a way out too easily and sometimes not meeting the standards that are set and could be harmful to all of us. The FDA is making sure to update its standards and regulations by taking in consideration the present day scenario, hence it is important to abide by these standards. I feel the  FDA has formed these standards to the best and are doing a great job.

Working in the medical device industry, it may seem like the FDA rules and regulations are too strict and unnecessary. Compliance and design controls are major things that some companies spend years trying to figure out. However whenever you get frustrated with the requirements, it is important to take a step back and look at the big picture. The FDA needed to make rules because of products that were available were causing public health issues. As products continued to slip by, more rules and regulations were implemented to prevent it from happening again. Therefore, although the FDA rules and regulations are strict, they are strict for a reason and it is the responsibility of medical device companies not to cut corners.

I think FDA's requirements and regulations are very strict, but I don't agree that this will limit future product innovation. I have three reasons. First, the FDA's strict requirements are to protect people's safety conscientiously, which is what they should do. In fact, they are improving people's lives by releasing only products they think are good. Secondly, many medical devices are easy to cause harm to the patients if they are not strictly supervised. Therefore, FDA should be strictly supervised. Thirdly, I think it will not limit future product innovation, but will promote future product innovation. Because the strict regulatory control system will make the quality of products higher and higher, which will stimulate companies to innovate products with better quality.

Personally, I believe it is necessary for the FDA to have strict guidelines and rules in relation to the development of and approval of medical devices. Since these products can have significant impacts on the health and well-being of people, it is important to ensure their safety and credibility of their claims. Therefore in terms of slowing down progress, I believe the problem rather lies in the complex perception given to navigating through the FDA and filling out the correct forms. As a result, I believe the process should be much more user-friendly to companies with instructions on how to go about the process written out in a more comprehensible manner. For instance, taking the development of your medical device through the FDA process should seem more like collaboratively working together with them to ensure that only safe and reliable products get the approval to be available on the market. Nonetheless, the same required tests and rules should remain to ensure that users are confident that FDA approved medical devices have been thoroughly tested to ensure the safety and well-being of people.

The FDA may appear too strict to industries trying to launch their medical device to the public market, but its guidelines exist to protect the wellbeing of the consumers and clients. In some ways, the FDA also protects the company by preventing future lawsuits and detrimental losses from selling faulty products. Rather than just hindering and blocking innovation, the FDA facilitates safe and effective product development by ensuring no crucial step is overlooked or rushed through. It holds companies accountable for hazardous side-effects of using the device, and will issue necessary recalls if the company itself refuses to do so. The FDA must remain unyielding in its standards, especially when dealing with new companies, since they are more subjectable to failure with little to no prior experience on medical device development. Also, the strictness of the FDA guidelines depend on the potential risks the device might pose. For example, a Class I medical device won't need to go through as many steps, forms, and boards of approval as a novel Class III medical device would be required to go through. While the FDA isn't perfect, the existing precautions it forces medical device companies to undergo outweighs any "slowdown" of innovation.

Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.

During AIDS epidemic, late 1980s, different activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV which caused lost of thousands of lives. Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options. All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated approval mechanisms. 

In April 2005, the FDA issued a statement asserting that cannabis had no medical value and should not be accepted as a medicine, despite a great deal of research suggesting the opposite.^[73] The supporters of medical cannabis legalization criticized the FDA's statement as a politically motivated one instead of one based on solid science. While the FDA has not approved marijuana it has approved THC (a compound found in cannabis) as an active ingredient for medicinal use. Critics argue that this approval is a politically motivated attempt to allow special interest groups to have patents over the substance, perhaps because the patents on previously patented competing substances have expired.

I feel that the process of FDA approval is a very long process but it is thus needed to ensure maximum assurance before the product is released in market. Sometimes the designs have to be altered towards the end in order to fit the FDA norms as a result of which the product takes time to reach out to people since many improvements have to be made

Yes, I do believe that the FDA rules are too strict, but in my opinion, it is needed as here we are dealing with products/things/food which directly affects human body so we need to be triple or 10 times sure before it is released into the market. It might happen sometimes that the product gets delayed but it is too sensitive a thing to give some slack to the releasing process.

I believe FDA is helping companies by being strict because once you build a medical device and follow FDA's rules necessary to develop this device then it will be easier for the companies to build more products as they now have an idea on how the FDA works what they have to submit in order to create medical device.

In some cases it may feel too tough to follow the FDA rules ,but in the long run or looking at the long term effect these rules are fair in my opinion. For example let us take the current situation we are in with Covid-19.The trail for vaccine some feel is taking too long where as Russia has its final Vaccine ready without taking it to the Phase-3 or proper human trail .This seems valid at this situation as we are facing The pandemic ,but as Dr.Fauci mentioned this is not a race to get the first Vaccine ready ,but also a safe vaccine that has no side effects(I am not sayin that the Russian vaccine is not effective .I am just making a point about why these rules even though they seem strict are relevant ) .So in this case it has to  pass all the regulatory rules before it reaches the common public.

So my perspective is that FDA seems to be harder on larger firms than smaller ones. Having worked with big companies such as Roche, Merck and Pfizer, the kind of questions and challenges we receive is more than what I saw with smaller firms including generics. I would project the same would be experienced in medical device firms. I believe FDA thinks because large firms have deeper pockets, they can do more in clinical studies, etc. I know sounds a little harsh, but having also worked for smaller firms, that is what I saw in support of the filings. 

The point of innovation where larger firms would have more involvement, seems to have an impact on timing and costs. In regards to quality, I feel that larger firms have stronger processes to support regulatory requirements. 

I believe that the FDA's protocols have shown adaptability especially during recent events due to Covid-19. The FDA was able to speed up the approval process to release ventilators due to the high demand when the virus began to quickly spread. However, when circumstances are not that dire, I believe that the product lifecycle is appropriate to ensure the safety and efficacy of products, especially Class III products. Depending on the urgency of the device, it may be appropriate to speed up the process at times, but with the current process, I believe there is still room for innovation with drugs, biologics, and medical devices.

The FDA's strict regulations are often based on incidents where the lax of regulations caused harm to the public. The 1902 Biologic Act was instituted after a diphtheria antitoxin caused a Tetanus outbreak. Many regulations are instituted as a reaction to certain incidents. Strict regulations help the FDA become proactive in preventing these incidents.  It is the FDA's duty to set a standard for the development of these products.

I absolutely believe that the FDA is not even remotely too strict. Not to blindly support the bureaucracy, testing, and red tape that comes along with getting a product approved by the FDA, but these steps exist for a clear reason. It is necessary to prove that a device not only functions but that it is safe for patients and users. With less oversight, products can be released that may hurt patients far more than they help them. In fact, we can see this in certain hip implants that were approved by the FDA under 501 (K)s. With less oversight and less required testing, these devices actually turned out to behave far differently from existing hip implants and caused granulation and metal poisoning to users. This was a failure of the companies and of the FDA for not being strict enough in testing and approving said devices. 

When it comes to medicine, its important to ensure that what is being created helps instead of hinders and thus agencies like the FDA need to be strict in approving devices to ensure that it remains such. 

At first glance of the FDAs second part of their mission statement, I was also thinking this same thing. If they say that they are "advancing the public health by helping to speed innovations that make medicines more effective", then why is it so hard and takes so long to get a device/drug cleared. After a while of thinking about it, however, I realized that it is necessary for the FDA to be this strict. These are human lives that use these devices. If the FDA was loose on the rules and what it takes to get a drug or device cleared, there would be little need for them. In short, I do believe that it is necessary for the FDA to be strict in order to fulfill the first part of their mission statement. That is  to protect the public health by accessing the safety, efficacy and security if human drugs and devices.