FDA examines warning letter appeal process for medical device makers

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While FDA enforcement may not be a concern for medical device companies when appealing a warning letter, the agency currently is reviewing its procedures for the appeal and dispute process.

FDA Commissioner Andrew von Eschenbach met with lawmakers after an appeals dispute between the agency and TMJ Implants of Golden, Colo.

TMJ and the FDA have been involved with an ongoing four-year dispute, which began with an agency warning letter about indication for TMJ’s medical devices. In April, Reps. Joe Barton, R-Texas, and John Shimkus, R-Ill., defended TMJ Implants, and sent a letter to von Eschenbach, questioning the agency’s practice of telling companies they can appeal a decision when it intends to proceed with enforcement actions.

During last week’s meeting, the commissioner acknowledged that the agency’s handling of the device company’s warning letter appeal was a “process failure,” as defined in the April 30 letter from Barton and Shimkus.

In the letter to the commissioner, the lawmakers noted that von Eschenbach said that FDA staff is addressing problems with the dispute process. The lawmakers wrote that he asked an assistant commissioner to examine the agency’s dispute resolution process and develop guidelines to improve it.

The FDA said it will follow up with House Oversight and Investigations Subcommittee staff to discuss details of its new internal operating guidelines and other steps taken in response to lawmakers’ concerns.