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U.S. Department of Health and Human Services

Radiation-Emitting Products

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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?

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Yes. The lead interpreting physician must oversee the quality assurance programs for both the certified facility and off-site FFDM units. 21 C.F.R. 900.2(x).

 

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

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