Does mammography experience acquired outside the U.S. count toward the requirements of the Mammography Quality Standards Act? That's just one of the questions answered in the latest guidelines finalized by the FDA's Center for Devices and Radiological Health this month.
It may not have a tantalizing title, but the "Final Regulations Document #2" does include a fair amount of practical information in the agency's answers to questions received on MQSA. But what if you don't want to wade through 56 pages to find out the difference between "self-referring" and "self-requesting" patients under the act?
Then check out the MQSA Policy Guidance Help System at www.fda.gov/cdrh/mammography/guidance.html, suggests Dr. Charles Finder, associate director of the Division of Mammography Quality and Radiation Programs.
The help system is still being updated with the answers found in "Document #2," but the keyword and topic search functionality make it more useful for people who need specific information and don't want to read reams of government documents. "That system, in a lot of ways, is more important than the final guidance," Finder said.
Indeed, those people who have immersed themselves in previous MQSA publications will find little new material in the finalized "Document #2," as only a few changes have been made made since the proposed version was issued last March, Finder said. The finalized document is so new that the Web version doesn't have an issue date on it yet; that will come when it finally gets published in the government's Federal Register.
The latest round of draft responses to MQSA inquiries is also on the Web site as draft "Document #3" at www.fda.gov/cdrh/mammography/1496.html. As always, members of the public are invited to make comments and suggestions on the draft before it becomes final.
And finally, there's a "Document #4" in the works as the CDRH continues to field questions about what MQSA really entails. "It's a continuing process, but hopefully we'll get fewer and fewer questions as we answer more of them," Finder said.
Info-seekers should keep in mind that the guidance documents contain both guidance and regulations, he added.
"The regulations are things that have to be followed. Guidance represents one, but not the only way, to meet the regulations," Finder said. To tell the difference, look for guidance language like "may," "would," "could," and "should" versus mandatory words such as "shall," "must," and "require."
By Tracie L. Thompson
AuntMinnie.com staff writer
January 21, 2000
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