Yes as @srg mentioned the 501k rates. Just to add ot the conversation as per Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV) through 2022: 2018 standard rate for 510k is $10,5666 and small business is…   Read more»

I agree with others that the Design History File (DHF) is a living document. The FDA states that ” the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved…   Read more»

There’s a new EU Medical Device Regulation (MDR) that will be effective in 2020 This article goes into the “6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation”: 1. Plan Ahead 2. Conduct a…   Read more»

This example is out of the scope of what I encounter with my job responsibilities but I agree with how others have stated that if the equipment is going to be taken a part and moved to a new location…   Read more»

Yes, I agree with Ashley that its good to set buffers in your schedule to account for the unexpected. At Sloan, if I’m working on a project-especially the development of a medical device- I always include buffers to my timeline….   Read more»

To add to conversation, I agree with @krp67 that people “fudging” the data is unethical but people are bound to do this in order to promote themselves in some way to advance, look good, etc. I agree that if I…   Read more»

Reading this discussion about FDA regulation and example of acupuncture made me think of whole body cryotherapy. I myself have actually done a few cryotherapy sessions and reading this was curious to see what the FDA had approved. Interestingly enough…   Read more»

As @hc255 mentions the burst test. I actually YouTube’d different burst tests and it is has proven extremely informative and entertaining. It is really interesting to watch the video examples to see how the different testing is done. Some even…   Read more»

@f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don’t think modern day technologies need a different classification system. I think it is still useful to a classification system based on…   Read more»

I think this is a portraying an emergency situation which would require a quick Yes or No to use an unapproved medical device. I think as we learned with IRB, that it would also need IRB clearance. I can’t think…   Read more»

I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and…   Read more»

I agree with @zw2 that FDA regulations aren’t perfect, but I think the regulations and guideline documents really set the bar to ensure to the best of the its abilities the safety and effectiveness of devices. Sometimes companies follow all…   Read more»

To add to the conversation, it is first to file in the U.S.-this means that if this really is a good idea for a commercially viable product, you should file before a potential competitor does. It used to be that…   Read more»

To add to the conversation, I think its important to select a good vendor. In selecting a vendor, you should meet with them and see if they have a client that would be willing to speak with you to discuss…   Read more»

Yes, I believe most projects have multiple priorities. At Sloan when we have medical device project in our group we usually break it down into I. Development-Scientific II. Development-Business III. Intellectual Property (IP) Protection and Prosecution. Development and IP are…   Read more»

I agree that it does require social skills and this classes forces you to experience real life situations. For example with the simulations you are assigned a group, you don’t get to select the people you work with that maybe…   Read more»

Just to add to the conversation of determining Significant vs Non significant risk medical device studies, the FDA has a guidance document. https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf The guidance document is intended to provide information and advice to sponsors, clinical investigators, and IRBs on…   Read…[Read more]

I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical device…   Read more»

I agree these simulations really allowed for us to think creatively on how to solve problems using methods we learned in lecture. I really enjoyed learning about planning and how important it is that all of the details are addressed…   Read more»

I think I would like to a Clinical Project Manager as @Devarshi mentions as a project manager you are able to interact with all departments through the different phases from initiation to closure. It would be exciting to oversee a…   Read more»