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Must the lead and audit physician(s) be listed as interpreting physician(s) at the facility?

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Yes. The lead and audit physician(s) must be qualified interpreting physicians and must also be listed as interpreting physician(s) at the facility so that their qualifications can be evaluated at the time of the inspection. 21 C.F.R. 900.12(f)(3), 900.2(u). This does not require that the physician(s) actually interpret mammographic examinations at that specific facility.

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Page Last Updated: 08/07/2014
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