Dr. Sackner-Bernstein directs the development and implementation of the Center's medical product safety programs with the goal of fostering innovation. In parallel, Sackner-Bernstein is the champion of the Center's initiative to reengineer as a matrix organizational structure. Since joining the Center last summer, Sackner-Bernstein's focus includes integration of engineering and medical aspects of product evaluation premarket with the needs for surveillance in the postmarket setting. Prior to joining the Agency, Sackner-Bernstein served as a consultant to the Center as a member of the Medical Device Dispute Resolution Committee, following membership as an ad hoc member of the Cardiovascular and Renal Drugs Advisory Committee. In parallel with his expertise in regulatory science and FDA operations, Dr. Sackner-Bernstein brings to his role 20 years of experience in clinical practice, clinical research and healthcare management, with that research experience in pre-clinical, firstin- human, proof of concept, pivotal and post-approval studies.

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