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 $2,642
2018 standard rate for PMA is $310, 764 and for small business is $77,691

I do think its fair for small…[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 design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a…[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 Thorough Review
3. Invest Time and Resources
4. Start Small
5. Adopt Early
6. Address Reclassification if Necessary

“Under the new…[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 and its a more complex situation, that it would require to be re-validated to see if there are any changes with equipment performance. For as @kak33…[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. I know the principal investigator/ inventor will sometimes be behind on providing deliverables and will sometimes be out…[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 were planning a project I would also submit a number that is on the higher end of the range because it’s always better to be under budget…[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 the FDA has actually posted info regarding whole body cryotherapy (WBC) on their website.…[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 just do it for the product themselves one entertaining one was for UPS “Burst Test is used to measure the…[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 risk, Class I, Class II, and Class III devices. I think they could maybe include more guidance documents regarding…[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 of many hospitals in the tri-state area that would allow one of their physicians to treat a patient with an unapproved device that wasn’t…[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 understand the directions on the label. I think having a problem with labeling on a product especially a device or drug would…[Read more]