Rating is available when the video has been rented.
This feature is not available right now. Please try again later.
Published on Apr 7, 2014
How do biomedical innovators begin to understand how FDA may regulate their novel technology? It turns out there is a lot of useful information on FDA’s website – if you know how and where to look. You can find out how the FDA is organized, and where your technology is likely to be reviewed; access (redacted) approval documentation for similar technologies to help inform your development strategy, and find resources – including guidance documents, webinars, slide decks, and case studies – developed to help innovators understand FDA’s regulatory approach.