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FDA Admits to Dispute Resolution ‘Process Failure’


Devicemakers may not have to worry that the FDA will begin enforcement against them while they are appealing a warning letter.

FDA Commissioner Andrew von Eschenbach met with lawmakers after they got involved in an appeals dispute between the agency and TMJ Implants. During the meeting, the commissioner acknowledged that the agency’s handling of the device company’s warning letter appeal was a “process failure,” according to a letter from Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.).

In an April 30 letter to the FDA chief, the lawmakers summarize the meeting, noting that von Eschenbach said FDA staff is addressing problems with the dispute process. They write that he asked an assistant commissioner to examine the agency’s dispute resolution process and develop guidelines to improve it.

The FDA is expected to 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.