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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Will the FDA maintain the confidentiality of any patient's surgical and/or pathology results which may be seen during an inspection?

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Yes. Inspectors will be checking to ensure that outcome results have been obtained by the facility and/or that there have been reasonable efforts made to obtain such results. The FDA-certified inspector will verify that a system exists to collect positive mammographic outcomes information. During typical inspections, inspectors may review patient’s surgical/pathology results or individual or aggregate physician medical outcomes audit information but will not routinely record, copy or retain this information.

Back to Medical Outcomes Audit Program

Back to Medical Outcomes Audit General Requirement