While the FDA does generally have the public’s best interest in mind, they should not be allowed to create mandates regarding diets and exercises. They should instead just give recommendations.  However, when it comes to COVID-19 vaccines, I think such…   Read more»

As listed by both answers, the reason why a 510k would be used is that the main function of the medical device and all its secondary functional parts of the item would have to be the same, and very minor…   Read more»

While I agree with the others that the FDA should not necessarily be given the authority to impose mandates, I do not believe that leaving that decision to just government bodies is the best solution either. Using today’s situation as…   Read more»

The debate between if one product that is considered hazardous vs a certain amount of it is okay to consume has been a long standing  debate between scientist and policy makers. However for this issue, I believe that with proper…   Read more»

There are very interesting opinions on both sides of the argument. While it has been recognized at general safe by the FDA, I cannot help but think of any long lasting effects when consuming it for a long period of…   Read more»

I am on board with @Jbarbee and @cm539. While the FDA approving products that include antifreeze is not unethical, the lack of transparency on the inclusion is what I find to be unethical. While the amount of antifreeze in these…   Read more»

If a new function is added to an existing class 2 device, than I believe a PMA would be necessary in order to ensure that: 1) The new functionality does not interfere with any of the existing functions of the…   Read more»

If a new function is added to a device then it will most likely require a PMA. If the device remains largely the same but with a slight change you can proceed with a 510(k). For example, to my understanding…   Read more»

I believe the FDA’s stance on this is ethical. If their studies have found that X level of antifreeze is safe to consume and there are no discernable effects from consuming products that have it, I would have no objections….   Read more»

I believe the FDA should not have the power to create mandates. The FDA’s role is to identify hazards whether in medical devices, medicine or food, not to write laws. Similar to the EPA, they are tasked with ensuring our…   Read more»

I think this is a great point. The FDA presents a mission statement that backs the responsibility of protecting public health by ensuring safety, which I assume the vaccine mandate is an example of. As you mentioned, the FDA presents…   Read more»

As others have said in this thread, a big reason is to save time, money, and resources. But, to go a little deeper into this topic, this means that links can be made where risks may involve two or more…   Read more»

@leshan I do like how you mentioned that communication AND listening is the most important part because no matter how good the project leader is communicating their ideas, it is still dependent on the other members of the group to…   Read more»

@cassiem I think you definitely identified the biggest factor when it comes to group projects and that is communication. It is rare that you will find the “perfect” group where everyone always does their assigned part well and in advance…   Read more»

I personally have not had the experience of being a PM, but I am able to recall a time that priorities shifted at my previous job.    I previously worked for a medical device company that was planning on submitting…   Read more»

I do not have experience in the field, so my answer will be in terms of group projects. In the beginning of a project, I like to sit down with the team and list our major goals. It will then…   Read more»

Choosing between those two roles, I would choose product development because the management side of a team does not interest me. I honestly could not see myself choosing either of those positions as a career. Compiling reports, working with the…   Read more»

I don’t believe that the antifreeze ingredient is unethical, but rather the lack of awareness is. I did a quick search, and I am shocked to the wide variety of products this ingredient can be found in. The chemical terminology,…   Read more»

For a manager to be a good manager, they need to be an effective leader. The manager should be well organized, have good communication skills, and, most importantly, trust the people that they are leading. By being organized, the manager…   Read more»

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….   Read more»