Radiation-Emitting Products

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.

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Back to Medical Outcomes Audit General Requirement

Page Last Updated: 08/13/2014
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