Booz Allen developed a set of recommendations based on the findings and analysis conducted
during the evaluation and documented in this report. Together, these recommendations are
intended to improve the medical device review process by reducing total review times, and
improving predictability, consistency and transparency. The priority recommendations that were
developed and published earlier in the study are also documented here, and are denoted as
such. For each recommendation, we have also provided suggestions for specific actions that
FDA might take to address the recommendation, as resources are available; however, FDA may
determine at its discretion to take action on these recommendations in alternative ways.