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 ...
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 nece...
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 t...
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 goi...
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...
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...
Reading this discussion about FDA regulation and example of acupuncture made me think of whole body cryotherapy. I myself have actually done a few cry...
As @hc255 mentions the burst test. I actually YouTube'd different burst tests and it is has proven extremely informative and entertaining. It is reall...
@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 cla...
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 w...
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 ...
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...
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 shoul...
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 cl...
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. Deve...