In the memo, Donna-Bea Tillman, head of the FDA’s device evaluation office, called on branch chiefs to inform her when they were asked to clear a new "indication" or use "that you have never cleared for that device type."
FDA reviewers do not typically contact an official at Dr. Tillman’s level when handling such applications, FDA scientists told the WSJ.
Dr. Tillman didn’t respond to the WSJ’s requests for comment, but the FDA said in a statement that her memo "reflects and is a furtherance of new direction."
This action follows a recent FDA report finding "definite threats" to the integrity of the agency’s approvals in the case of its approval of ReGen’s Menaflex orthopedic knee device in December.
Read the Wall Street Journal’s report on the FDA’s approval of orthopedic devices.
