The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s
FDA Law Blog
FEBRUARY 28, 2023
Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. As anyone who has ever worked on a lengthy and/or complicated AI response knows, these responses do not always fit neatly in a text box. By Adrienne R.
52 
Let's personalize your content