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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Full Field Digital Mammography (FFDM) Certification Extension Program

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Discussion

Until an accreditation body has been approved to accredit your specific model full field digital mammography (FFDM) unit, FDA will continue its process for extending the certification of an already certified facility to include these specific model FFDM units. Until otherwise notified by FDA, a facility with an FFDM unit (that does not have a corresponding approved accreditation body) will be exempt from the MQSA accreditation requirement but must request FDA to extend its current certification to cover its unaccredited FFDM unit. Requests for FFDM certification extension need to include all the information listed in the document MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography (FFDM) and should be forwarded to:

FFDM Certification Extension Program
Division of Mammography Quality and Radiation Programs
FDA/CDRH/OIR
10903 New Hampshire Avenue
WO66-4621
Silver Spring, MD 20903-0002
Phone: 301-796-5710
Fax: 301-847-8502

After a decision has been reached, you will receive either a Letter of Acceptance or a Letter of Denial for your FFDM unit(s). If you receive a Letter of Acceptance, your FFDM unit will be added to your certificate and you may begin to use it for clinical examinations. Your facility must maintain its accreditation status for at least one mammography unit in order to maintain its certification status when utilizing an FFDM unit. 21 C.F.R. 900.11(a). Your facility is also subject to an annual onsite MQSA inspection of its FFDM unit at the same time its accredited unit(s) is/are being inspected.

If you receive a Letter of Denial, we will work with you to resolve the problems preventing your acceptance.

Questions

  1. Does a facility have to have its FFDM unit accredited?
  2. What information will we need to provide in our request for FFDM certification extension?
  3. How does a facility apply for FFDM certification extension?
  4. What is FDA's FFDM review process?
  5. Does the FFDM unit have to be in the same location as the screen film unit?
  6. Our FFDM unit is not at the same location as our certified facility. Is our lead interpreting physician still responsible for the quality assurance program of the off-site FFDM unit?
  7. Which FFDM units have been approved by FDA?
  8. FDA has extended our certification to include our FFDM unit. Are there any special requirements we need to be aware of?
  9. Which FFDM units can be accredited by which accreditation bodies?
  10. We have been using our FFDM unit under FDA’s film-screen certification extension policy. Now that there is an accreditation body for our model FFDM unit, what do we need to do to have the unit accredited? We were keeping our old film-screen-unit just to be eligible for the certification extension policy. Do we still need to keep this film-screen unit?
  11. We have been operating our FFDM unit under FDA’s film-screen certification extension policy by linking our unit with a film-screen facility at a different location. Now that an accreditation body has been approved for our FFDM model unit, must we become accredited and certified as our own independent facility?
  12. Our radiology group has two mammography units at the same location. Can each unit be accredited by a different accreditation body (dual accreditation)?
  13. What actions must we take before we begin using our FFDM unit on patients?
  14. FDA has approved a Computed Radiography (CR) system for mammography use. From an MQSA standpoint, are there any differences between a CR system and a full field digital mammography (FFDM) system?
  15. Under the Certification Extension Program, does a facility wishing to add a CR system to a screen film (S-F) unit need to keep accreditation for an existing unit?
  16. If we have multiple S-F units and plan to use CR with all of them, do we need approval to extend our certification to add CR to all of them?
  17. What inspection costs are associated with CR certification?
  18. How will an inspector inspect a CR unit being used under the certificate extension program?