Participate
in detailed discussions on the US Food and Drug Administration’s (FDA)
ongoing review of its 510(k) program and potential changes to it. These
thought provoking sessions with FDA officials will be led by FDA law
expert Jeffrey Shapiro, JD, Hyman, Phelps & McNamara This program
will identify current CDRH 510(k) staff concerns about the 510(k)
process as well as anticipated short-term changes and potential
long-term changes.