Radiation-Emitting Products

Definition of Certificate

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Citation:

900.2(h) Certificate means the certificate described in section 900.11(a).

Discussion:

After October 1, 1994, all mammography facilities are required to have an MQSA certificate issued by FDA or the Certifying State to legally perform mammography. To obtain an MQSA certificate from FDA or the Certifying State, facilities are required to be accredited by an approved accreditation body or other entity, as designated by FDA, and to meet the quality standards as published in 900.12. 21 C.F.R. 900.11(a).

By law, MQSA certificates must be prominently displayed where they can be viewed by mammography patients. 42 U.S.C. 263b(b)(1)(A)(iii).

Questions
  1. Where does a facility with more than one patient reception area display its MQSA certificate?
  2. Can a facility with a large Spanish-speaking population get a Spanish-language MQSA certificate?
  3. A facility has changed its name but has the same owner, personnel, and equipment. Is the MQSA certificate still valid even though the facility name is different?
  4. A facility moves or relocates and the address on its certificate is no longer correct. Is the MQSA certificate still valid?
  5. What should a facility do if it closes or decides that it will no longer provide mammography services?
  6. Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?