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 $...

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...

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 Ahea...

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 ...

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 inc...

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 t...

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 ...

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 h...

@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 ...

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 ...

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...

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...

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 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 di...

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. I...