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U.S. Department of Health and Human Services

Radiation-Emitting Products

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How will an inspector inspect a CR unit being used under the certificate extension program?

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Using his/her laptop computer, the inspector will download for inspection the record for a mammography unit(s) that uses CR in the same manner as any other FFDM unit, and then open the applicable inspection procedure screens. If a unit(s) is being used for both S-F and CR on the same physical unit(s), the inspector will need to download a separate S-F record, as well.

If an inspector determines that CR is being used on an S-F unit(s) for which there is no certificate extension approval, the inspector will:

  1. add a new record for the CR unit(s) into the database (e.g., with the same model, description, and serial number as the S-F unit(s) but with an image receptor type of CR); 
  2. mark it as unaccredited (resulting in a Level 1 or 2 inspection observation);
  3. answer the mammography equipment evaluation (MEE) question and all of the applicable questions in the QC records and Survey Report sections accordingly; and,
  4. instruct the facility that it should stop using the unit(s) until it applies to FDA for certificate extension on the unit(s) and has obtained certificate extension for the unit(s).

If a facility is performing both S-F and CR mammography using the same physical unit(s), the inspector will treat the inspection as 2 separate units and the facility will be billed accordingly.

Back to Full Field Digital Mammography (FFDM) Certification Extension Program