FDA to release new standard for x-ray mammography devices

Standard will define performance requirements

The Food and Drug Administration is on the verge of releasingnew criteria that will directly impact the design of future mammographyequipment. The criteria will detail the performance requirementsthat must be met by conventional x-ray equipment used to screenfor and diagnose breast cancer. As such, these requirements willbecome a de facto standard for the mammography equipment industry.

"If a manufacturer makes equipment that doesn't meet thisstandard, it probably will not be a very popular piece of equipment,"said Charles Showalter, chief of the FDA Mammography StandardsBranch. "Manufacturers will be very interested in makingequipment that will comply."

The new requirements have been written, but have not yet beenreleased because the draft is undergoing review at the FDA, theDepartment of Health and Human Services and the Office of Managementand Budget. If and when they pass muster, possibly this month,they will be published in the Federal Register, the government'sofficial mouthpiece. The mammography community will then have90 days to submit comments.

The National Electrical Manufacturers Association (NEMA) inWashington, DC, has already begun working with the FDA on thismatter. An early draft of the regulations released by the agencylast January raised concerns at NEMA that the final regulationscould make obsolete a large portion of equipment in use at mammographyinstallations.

"Our point is that if facilities have to pay a lot ofmoney to come into compliance, they might just decide to shutdown," said Vicki Schofield, industry manager for NEMA.

In an effort to assist the FDA in assessing the economic impactof its new regulations, NEMA conducted a survey of associationmembers that manufacture or sell mammography equipment, askingthem to provide insight into the specifications of their customers.A detailed picture of the installed base aided the FDA in estimatingthe cost facilities would incur if a standard were put into effectthat asked too much of the mammography community.

Economic considerations were factored into the new regulations,according to Showalter.

"If a standard went into effect that caused 50% of theequipment in the country to be replaced, that would be a hugeeconomic impact," Showalter said. "So we are tryingto develop an appropriate phase-in."

NEMA is also concerned that equipment criteria adopted todaywill retard the development of innovative technology in the future.

"If you write the standard too tightly, the industry islost in a time warp," Schofield said.

Publication of the new regulations will likely prompt someof these concerns, Showalter said. But he believes the concernswill be unwarranted. The FDA foresaw that regulations aimed atsetting equipment standards could be a disincentive for engineersto develop innovative technology, he said. That is why, in September1994, the agency published a document called "AlternativeStandards," which provides a mechanism for overcoming thispotential hurdle.

"If a facility or manufacturer believes they have builta better mousetrap, they can apply for an alternative standardand say that these other standards do not really apply to theirequipment," Showalter said. "That gives us the meansto deal with new technology."

The new criteria for mammography equipment are not the sameas the requirements already in use as part of the MammographyQuality Standards Act, which define the level of quality expectedfrom the equipment and staff of mammography facilities. The MQSArequirements are based on standards of performance developed bythe American College of Radiology.

"There are certain performance criteria that have to bemet, but ACR doesn't tell you exactly what values your equipmentmust have," Schofield said.

The standard to be released soon by the FDA will do that, butit will not be a radical departure from the status quo, Showaltersaid.

"Many of the things in our draft documents are taken fromdocuments developed by the ACR," he said. "There isnowhere near a one-to-one correspondence, but they are based onsome of the best thinking at ACR."