What was the effect of involving the elected officials?
The elected officials helped to obtain meetings with the FDA Commissioner and the Assistant Commissioner of Integrity and Accountability. This coordination ultimately produced a decision that Dr. Schultz, the Director of the Center for Devices and Radiological Health (CDRH) would lead the review of a third 510(k) submission. Dr. Schultz called for clinical and scientific input from the Orthopaedic and Rehabilitation Devices Advisory Panel to aid his review of the Menaflex device. The panel meeting lasted approximately eight hours, and at its conclusion the panel members indicated they believed the device was as safe and effective as predicate surgical meshes for the indicated use in patients with both chronic and acute meniscus injuries. A transcript of the Advisory Panel can be found at: http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#orthopaedic.
