Mammography Recordkeeping Guidelines


900.12(c)(4)(i),(ii): Recordkeeping. Each facility that performs mammograms:

(i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 years, or not less than 10 years if no additional mammograms of the patient are performed at the facility, or a longer period if mandated by State or local law; and

(ii) Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or healthcare provider of the patient, or to the patient directly.

For more information visit the FDA at The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9


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