FDA Regulations and Medical Device Pathways to Market

[@meenakshirana6467]

It's a very informative presentation. Thank you very much for uploading it.

[@Elizabethterhune]

Great presentation, thank you! I used it to help study for my bioregulations exam. Super helpful.

[@j.6946]

Great presentation, thanks so much. This is very helpful.

[@MysterERaps]

I'm curious how 300k to a million for initial costs on a class 1 device breaks down, budget wise

[@saurabh5534]

In 510k, the product gets cleared by USFDA but you mentioned as approved? please clarify sir

[@dennychoi4439]

Great video ! thanks a lot

[@dianawright6975]

Can anyone have one

[@dianawright6975]

For my own use. Plus listens for me. I do have medical problems.

[@dianawright6975]

And cost

[@leeswanson2766]

CFR = Code of Federal Regulations

[@sptzk7133]

CFR does stand for code of federal regulations however the federal register or congressional federal registry he referred to seems to be the daily discussions of these laws and once they are finalized they are introduced into the CFR. So it seems it is reasonable to misspeak, I only look this up because I wasn’t sure if the lecture was credible, but looks like it is:)