Warning-Letter Appeals Process Under Review

FDA Commissioner Andrew von Eschenbach admitted to Congress that the dispute over TMJ Implants' appeal of a warning letter was "a process failure," and said the agency is currently reviewing its procedures for handling disputes and appeals of warning letters, HealthImaging.com reports.

May 9, 2008

1 Min Read
Warning-Letter Appeals Process Under Review

Transforming FDA LogoFDA Commissioner Andrew von Eschenbach admitted to Congress that the dispute over TMJ Implants' appeal of a warning letter was "a process failure," and said the agency is currently reviewing its procedures for handling disputes and appeals of warning letters, HealthImaging.com reports. An assistant commissioner is leading the review. The commissioner said FDA staff will follow up with the House Oversight and Investigations Subcommittee staff when the new procedures are in place.Reps. Dan Barton (R-TX) and John Shimkus (R-IL) sent an angry letter to von Eschenbach last month over the treatment of TMJ Implants. CDRH issued a warning letter to the firm for not filing 17 Medical Device Reports, but the company disputed that MDRs were warranted. The firm says its appeal was never substantively reviewed before an FDA administrative law judge ruled against it and ordered it to pay $630,000 in fines.

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