In my opinion, the overall responsibility of the FDA to ensure all drug/food/medical devices meet current regulatory and safety requirements is a super important one. Without the FDA, we cannot guarantee that some of the medicines or food we buy each and every day is safe to consume or even keep in our homes. In my experience with working in an FDA-regulated industry, there are extremely strict standards to adhere to, but I understand these standards are necessary for the assurance of the quality and regulation of these goods. I don't think I would feel comfortable with buying a drug without the FDA auditing and visiting these corporations, making sure they are following regulations. There are some companies who are simply looking for profit, and they may seriously harm the public if it means that they can make more money off of them. 

I believe the most important responsibility of the FDA is to review and approve prescription, over the counter, and generic drugs. I believe that this is the most important responsibility of the FDA because of how profitable drug development can be for pharma companies. Due to the large profit margin, companies work to bring as many drugs to the market as possible. In some cases, these companies value the profit over actually helping people. This can lead to them not fully testing the drug's side effects or even falsifying clinical trial results. This can have catastrophic results because by the time the negative side effects can be discovered hundreds if not thousands of patients could already have been exposed to the drug. Therefore, the FDA plays a crucial role in protecting the public from negligent healthcare companies.  

The mission statement of the FDA on their website is as follows “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.” I believe that the most important responsibility for the FDA is that they advance the public by speeding up innovations and medical devices by making sure that they’re effective, affordable to the public, and safe based on scientific data using their regulations. They ensure that the products meet certain requirements before they are introduced to the public and market. For example, drugs usually go through a twelve step review process to ensure that they are safe and effective. Furthermore, the FDA has taken other minor responsibilities. They try to ensure that even patients with rare diseases have medical devices that might improve their conditions. For instance, there is a program called Orphan Products Grants Program that gives out grants for the development of these devices.

I agree with all the responses above. I believe the most important role of the FDA is to ensure that all foods, drugs, and medical devices that are being made, are made to a high standard to ensure everyone’s safety. I think it is so important that they go to warehouses and factories or anywhere else these products are being manufactured and shut them down if they are not following the rules and regulations in place. This gives the public the peace of mind that when something is FDA approved, it is safe for consumption. Their overall ability to regulate what products and how they are made is extremely important, because it sets the precedent that companies must follow to make themselves successful. Overall, I think that the FDA has so many critical roles to keep our society safe and all their roles are important to everyone’s safety and daily life.

I believe the most important FDA responsibility as mentioned by my peers is advancing public health by expediting innovation, hence the case, with companies such as Pfizer-BioNTech receiving emergency use authorization by the FDA for the COVID-19 vaccine. However, prior to this weeks lecture I did not know that the FDA plays a role in the nations counterterrorism capability. Reading into this more, the way the FDA fulfills this responsibility includes ensuring the security of food supply by monitoring availability and protecting the public from chemical, biological, radiological, nuclear, and infectious disease threats which is done by fostering the development of medical countermeasures.

Here, FDA refers to the Food and Drug Administration and is one of the agencies within the United States and belongs to the Department of Health and Human Services. The FDA includes an office of commissioner along with four other boards that look over the key functions or duties of the agency including foods and veterinary medicine, medical products and tobacco, operations, and global regulatory policy and operations. The FDA agency includes a wide range of responsibilities and a few of them to mention are providing protection the public health by ensuring the quality, security, safety, effectiveness of both human and veterinary vaccines, drugs, and other types of biological products, and even medical devices, it is also accountable for the safety and security of most of the country’s food supplies, dietary supplements, cosmetics, and other products that give of radiation, testing and ensuring drugs are proposed for public use are secured and effective in curing or preventing diseases, it also helps in ensuring the dietary and cosmetics are labeled properly, helps in safeguarding human from most of the electronic device or product radiation, it regulates tobacco products too, and it also ensures to have advancement in public health by facilitating to gear up new innovative products or devices into the market. FDA plays a key role without FDA the entire human and veterinary life is at risk.

The most important responsibility of the FDA is to guarantee the safety of the public by implementing rules, regulations and laws to products that can be consumed and utilized by the public. I work for a company that is regulated by the FDA and the Food Safety Modernization Act (FSMA). The manufacturer is responsible for complying with all the safety guidelines provided by the FDA.  The FDA requirements for Food and Beverages companies are vague.  However, the Industry I work for, they have to provide a series of assessments to make sure that our products are secure for consumption at every level. Such as Good manufacturing Products, Hazard Analysis & Critical Control Points (HACCP), etc. Starting from the raw materials all the way to when the product is shipped to the customer, risk evaluations are taken in order to prevent contamination. Food safety is always addressed to the control of chemical, biological and physical hazards. Even though we have different procedures in how to market our products, the FDA oversees our facility’s standards to protect consumers and to promote public health every step of the way.  

The most important role of the FDA is the first part of their mission statement which mentions the "responsibility of protecting the public health assuring safety, efficacy, and security of all human/vegan drugs, bio products, devices, food supply, cosmetics, and products that emit radiation". This organization was established in 1902 in response to a tetanus outbreak. Although more reactive than proactive it's important that as problem arises regarding public health there are laws or acts that ensure manufacturers and etc. are keeping consumer health as a number one priority. 

The most important FDA responsibility is to ensure the efficacy of drugs and medical devices as well as ensure the safety of these products. This is done by ensuring that the products are meeting requirements during the development of the device through a 510k or a premarket approval application. Other documents and regulations are required to be met during development if the device requires a clinical test. The FDA also continues monitoring devices after production to ensure that the device is safe for clinical use and continues to meet new regulations. The FDA also educates consumers on the devices and drugs to ensure that they are able to select the best products for their medical needs. This is done through providing the consumers with scientific information on the devices.

The Food and Drug Administration (FDA) has a lot of important duties, amongst theses are ensuring the safety and efficacy of the and human and drugs, biologics, and medical devices. The FDA is tasked with making sure the medical products and devices released by companies to the public abide by strict standards. There are 4 ways in which a new medical device can be approved by the FDA. The device is classified as either a class 1, 2 or 3 device; additionally, a device can also be as approved via alternative pathways like the Custom Device Exception. Class 1 devices are considered low-risk and include items like elastic bandages; they are exempted from evaluations like Pre-market Approval (PMA). If the developers are able to prove their products is similar enough to an existing, approved product. Class 2 device are moderate-risk, they can achieve FDA certification through a 510K, or Premarket Notification. Finally there Class 3 devices, this include items like hip implants. These particular devices are considered high-risk and must undergo a stricter Pre-market Approval Process before they can be approved by the FDA. While this does make our jobs as Biomedical Engineers a bit more tedious, I believe it is well worth it to ensure the safety and wellbeing of the public.

In my opinion, the FDA’s role in ensuring the safety of the products on the market is of the utmost importance. We would be living in a very scary world if there was no regulatory agency scrutinizing companies, especially in the context of this class. They do this in many ways. One way is by ensuring the product does whatever the company claims it should do in order to deter false advertisement. Additionally, the FDA also ensures that the company does proper testing on the product to make sure it is safe and does not produce any unexpected adverse effects. An example of how dangerous false advertisement could be without FDA regulations is – a groundbreaking new cancer treatment came to market claiming nearly double the median survival rate of competitor products, but instead actually has no effectiveness for curing cancer, or worse promoted cancer growth. In that case people may not survive due to not having accurate facts about what medications to take. It’s one thing for consumers to get scammed of their money due to false advertisement, but it is more important to not jeopardize the consumers health due to the incompetence or negligence of the producer of the products on the market.

The most important responsibility of the FDA, besides the obvious regulatory responsibilities, is to be as transparent & clear cut as possible. For the benefit of not only the consumer, but of the product developer as well. As Dr. Simon mentioned in his lectures this week, the FDA mandates design controls by law. If these mandates were less verbose & more easily accessible by those in the field; the product development timeline could be shortened by months. Often we hear of novel medical devices with promising data stuck in the long FDA approval process. More often than not this process is red tape & bureaucracy. Of course, this process does weed out dangerous & harmful products. I am proposing that it be the FDA's goal to update their regulatory process to modernize it.

I believe that the most important responsibility of the FDA is to stay true to serving the people and not lobbyists or politicians. Without FDA regulations, US markets would be a free for all and that would be a scary place. You could potentially buy something without knowing if it actually did what it was supposed to do. Your treatment could be fatal by design and you would know it. It is good that it takes a while for devices to go through the FDA process to ensure that it is safe for the community. On the medical device side, I think that even though there is room for improvement when it comes to streamlining the process or modernizing it more, it is doing a pretty good job at making sure we have access to safe medicine/medical products. I believe that food regulations, on the other hand, really need to be cracked down upon and scrutinized more. I recently came back from Europe and the difference in the quality in food (even fast food!) was very noticeable. It left me wondering why our medical regulations were so strict and effective (in a good way) yet lacked in protecting public health (by means of prevention and quality of food) in the food industry compared to the EU. 

I can say that one of the most critical responsibilities of the FDA is ensuring the safety and efficacy of drugs, biologics, medical devices, and other products it regulates. This includes reviewing and approving new products, monitoring developments once they are on the market, and taking action to protect public health when necessary. The FDA's responsibility in this area is critical because these products directly impact the health and well-being of patients and consumers, and ensuring their safety and efficacy is crucial for maintaining public trust in the healthcare system.