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. There are additionally places to provide attachments for test reports and other supporting documents. By Adrienne R. New Labeling Requirements.
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