FDA may form new group for MQSA

August 25, 1993

The Food and Drug Administration may soon have a dedicated divisionto implement the Mammography Quality Standards Act of 1992 ifa proposal by the Center for Devices and Radiological Health isapproved by the agency. Tentatively called the Division of

The Food and Drug Administration may soon have a dedicated divisionto implement the Mammography Quality Standards Act of 1992 ifa proposal by the Center for Devices and Radiological Health isapproved by the agency.

Tentatively called the Division of Mammography Quality andRadiation Programs, the organization will be located under theOffice of Training and Assistance, according to Richard Gross,assistant director for liaison at the OTA.

"It's informal until all of the paperwork gets handled,"he said. "But that's the direction the Center director (Dr.Bruce Burlington) is going to recommend."

Although the responsibilities for the new division are stillbeing discussed, the unit will take over radiation programs previouslyhandled by the former Division of Technical Development. The mostvisible of these programs is the Nationwide Evaluation of X-rayTrends, a cooperative program with the Conference of RadiationControl Program Directors, Gross said.

The reorganization of the OTA has been talked about for overa year, Gross said.

"When the responsibilities of the MQSA were assigned tothis office, it was another impetus for restructuring and tryingto figure out a new approach to things," he said.

A dedicated division will aid the FDA in developing its programfor implementing MQSA, Gross said.

"You have to have a consistent, centralized organizationto get (the program) developed," he said. "A lot ofdevelopmental activities are required. The primary function inthe beginning will be to develop standards."

Under MQSA, every mammography unit in the U.S. will have tobe certified by Oct. 1, 1994, or cease operations.

The division's interim director is Joseph S. Arcarese. Becausehe is retiring on Nov. 1, a recruiting announcement for a permanentdirector has been released, Gross said.