ANSWERS
03/29/1996

<TITLE> FDA PROPOSES FINAL MAMMOGRAPHY STANDARDS </TITLE>
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T96-20                                       Sharon Snider 
March 29, 1996                               (301) 443-3285


            FDA PROPOSES FINAL MAMMOGRAPHY STANDARDS 

     The Food and Drug Administration today proposed regulations
that will ensure that all women have access to high quality
mammography services.
      The proposed rules expand and strengthen interim regulations
in place since late 1993.  When final, the new rules will be a
major step toward FDA's implementation of the 1992 Mammography
Quality Standards Act (MQSA).
     The following can be used to answer questions.
     In addition to requiring that mammography facilities meet
quality standards, MQSA requires facilities to be accredited by an
FDA-approved accreditation body, certified by FDA, and inspected
annually.  To date, nearly 10,000 facilities have been accredited
and 80 percent have had their first inspection.   Prior to 1992,
only about 46 percent of facilities were accredited and many
facilitiies were never inspected.
     The proposed regulations would:
     *  Strengthen interim requirements for personnel doing
mammography to ensure they are adequately trained and qualified to
conduct mammography examinations and interpret mammograms;
                             -MORE-

                              Page 2, T96-20, Mammography Standards
     *  Strengthen requirements to ensure that mammography
equipment meets appropriate design and performance characteristics;
     *  Expand requirements for reporting results of mammograms to
ensure that doctors and patients are quickly and fully informed of
results so that any follow-up testing or treatment can begin
immediately; 
     *  Add a consumer complaint requirement to ensure that
complaints from patients are adequately followed up; and
     *  Add requirements for special methods of examining women
with breast implants and training of personnel doing the exams.
     In addition to these proposals, FDA is asking for comments on
alternative approaches to assuring quality mammography that would
minimize administrative requirements for mammography facilities.
     The public has 90 days to comment on the proposed regulations. 
Final regulations are expected to be published in 1997.
     The names and locations of FDA certified mammography
facilities are available by calling the Cancer Information Service
at 1-800-4-CANCER (1-800-422-6237).   
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