FDAnews Device Daily Bulletin

Cyberonics Submits Response to FDA Warning Letter

Jan. 25, 2005

Cyberonics has submitted its response to the FDA warning letter dated Dec. 22, 2004, regarding nonconformities with current good manufacturing practice requirements of the quality system regulation for medical devices, as specified in Title 21, Code of Federal Regulations, Part 820 during a meeting with the Dallas District Office.

The warning letter said Cyberonics' initial responses were incomplete and did not satisfactorily address the specific Form-483 observations and issues identified in the letter.

"Cyberonics is committed to working with the Dallas District Office to resolve the warning letter observations in a timely manner," said Robert Cummins, Cyberonics' chairman of the board and CEO. "We are also working diligently with FDA's Center for Devices and Radiological Health (CDRH) to obtain CDRH's decision regarding the approvability of our treatment-resistant depression Expedited Review PMA-S by Jan. 31," he said.