Radiation-Emitting Products

Can experience obtained using investigational Full Field Digital Mammography (FFDM) units count toward the 8 hour mammographic modality training requirement? Radiological Technologist

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Yes, Radiological Technologists who began performing examinations using FFDM investigational units (units that were used for research purposes before being approved by FDA for commercial distribution), are considered to have met the requirement for  8 hours of training with that mammographic modality.  However these radiologists technologists must either attest to or document that they were performing examinations.  Attestation should be done using an FDA attestation form (or equivalent) indicating where and when the FFDM examinations were performed.  An example of acceptable documentation would be a letter from an appropriate official at the facility where the examinations were performed.  For more information, see acceptable documents for radiologic technologists.

Radiologic Technologists who begin working with non-investigational FFDM units after April 289, 1999 must document that they had 8 hours of training in that mammographic modality before independently providing FFDM examinations.  Radiologic technologists must document this training using he same methods as those used to document other training (certificates, letters from the training provider, etc.)  For more information, see acceptable documents for radiologic technologists in the Policy Guidance Help System (PGHS).

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Page Last Updated: 06/26/2014
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