HIMA/FDA meeting
This article was originally published in The Gray Sheet
Executive Summary
The board of the Health Industry Manufacturers Association met with members of the Center for Devices and Radiological Health Dec. 8 in Washington, D.C. Representatives of the device center included Director Bruce Burlington, Deputy Director for Regulation and Policy Joseph Levitt, Deputy Director for Science Elizabeth Jacobsen, and Director of the Office of Device Evaluation Susan Alpert, according to HIMA staffers. During the meeting, HIMA President Alan Magazine articulated the association's position that there are fundamental problems with the philosophy at CDRH that need to be addressed, including the center's intrusion into the practice of medicine, law enforcement mentality, and adversarial attitude toward the U.S. device industry