FDA reviews warning-letter appeal process for device makers

05/9/2008 | HealthImaging.com · FDAnews

FDA Commissioner Andrew von Eschenbach has asked an agency official to review the dispute-resolution process for device makers' warning letters and to create guidance to enhance the procedure, according to a letter summarizing a meeting von Eschenbach had with Reps. Joe Barton, R-Texas, and John Shimkus, R-Ill. During the same talks, von Eschenbach called the FDA's handling of TMJ Implants' warning letter appeal a "process failure," the letter from the lawmakers said.

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HealthImaging.com · FDAnews

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