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
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. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). Learnings on how eSTAR works Starting Too Early.
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