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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Application to an Accreditation Body

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Citation:

900.11(b)(1)(i)(ii): Application.

(1)  Certificates.

(i)  In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by FDA. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1).

(ii) Following the agency’s receipt of the accreditation body’s decision to accredit a facility, or an equivalent decision by another entity designated by FDA, the agency may issue a certificate to the facility, or renew an existing certificate, if the agency determines that the facility has satisfied the requirements for certification or recertification.

 Discussion:

Facilities should not apply directly to FDA or the Certifying State for certification. To be MQSA certified, a facility must first apply to, and become accredited by, an FDA-approved accreditation body. Currently these are:

American College of Radiology (ACR)
Mammography Accreditation Program
1-800-227-6440

Arkansas Department of Health
Division of Health
Radiation Control Section
Mammography Program
1-501-661-2301

Mammography Accreditation Program
Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
1-515-281-3478

Texas Department of State Health Services
Mammography Accreditation Program
1-512-834-6688 extension 2246

The States of Arkansas, Iowa, and Texas accredit facilities located within their respective States. Under MQSA regulations, a facility located in a State approved by FDA as an accreditation body may be accredited by the State or by the ACR. 21 C.F.R. 900.4(a)(7). State law may require facilities to meet additional requirements. These State requirements are independent of MQSA, and facilities must, for State purposes satisfy all such regulations in addition to MQSA requirements. The facility may want to contact the State about its requirements.

The accreditation body will notify FDA or the Certifying State after it has determined the initial accreditation application is acceptable or when a facility has been accredited. The FDA or the Certifying State will then issue a six-month provisional, or a three-year MQSA certificate to the facility as appropriate. The MQSA certificate must be displayed prominently where patients can easily see it, such as the patient reception area. 42 U.S.C. 263b(b)(1)(A)(iii). A facility may not lawfully perform mammography unless it has received its MQSA certificate (or a 45-day Interim Notice to be displayed temporarily in lieu of an MQSA certificate.)

Accreditation and certification are valid for up to three years. Facilities must reaccredit prior to expiration of their MQSA certificates. Renewal MQSA certificates will be issued upon completion of reaccreditation and notification of FDA or the Certifying State by the accreditation body. Facilities should allow at least six months for the reaccreditation process to be completed, since reaccreditation should be expected to take as long as initial accreditation. It is the responsibility of each facility to apply for and complete reaccreditation before its MQSA certificate expires. Failure to do so may result in the facility being uncertified and unable to lawfully perform mammography.

 Questions
  1. Must mammography units that are used exclusively for special interventional purposes (localization, biopsy, or specimen radiography) be accredited? Must a facility that performs mammography only for such special purposes be accredited and certified?
  2. We have a mammography unit that is used solely for interventional mammographic procedures. The unit is not MQSA certified. During the course of these interventional procedures, we take mammographic images. Because our unit is not MQSA certified, what restrictions exist on the mammographic images we may perform during such procedures?
  3. Must a facility be certified if its mammography units are used exclusively for training purposes?
  4. Our facility is currently undergoing accreditation. We meet all MQSA regulatory requirements. However, our accreditation body recommends certain actions that are more stringent than those in the regulations. If we follow MQSA regulations (but do not meet all those recommended by the accreditation body), can our facility be denied accreditation?
  5. Since loaner, demonstration, and prototype mammography units are temporary, must these units be accredited? What steps should a facility take to ensure that it remains in compliance if it uses these units for mammography?
  6. Facilities under the same ownership and/or management perform mammography at different locations. Must each of these facilities be uniquely accredited and certified?
  7. When a certified facility purchases a new mammography unit, what steps must the facility take before the unit can be used for mammography?
  8. What are the requirements for accreditation and certification of mobile units? Can mobile units be accredited as additional units of a stationary facility?
  9. A facility moves or relocates and the address on its MQSA certificate is no longer correct. Is the MQSA certificate still valid?
  10. The individual who signed the facility's application for accreditation resigns or retires and a replacement is named. Should the facility notify its accreditation body or the FDA or the Certifying State regarding the change of a designated facility contact?
  11. Is xeroradiography banned under MQSA?
  12. We are planning on moving our mammography unit. Whom do we need to notify about the move?