Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations

Streszczenie

The Food and Drug Administration (FDA) is presenting Booz Allen Hamilton's high priority recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 to 2017. The assessment is described in section V, "Independent Assessment of Review Process Management", of the commitment letter entitled "MDUFA Performance Goals and Procedures" \1\ (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The high priority recommendations are the first of a series of deliverables, as outlined in the contract statement of work,\2\ to be published as part of Phase 1 of the assessment. ---------------------------------------------------------------------------