Will the facility be responsible for patient/physician notification that may result following the AMR?

Yes. If the AMR indicates that notification of patients and physicians is necessary, the FDA or certifying State will require the facility to notify patients and physicians of the identified problems, consult with FDA or the Certifying State in developing the patient/physician notification, and ensure that the appropriate audience is reached. 21 C.F.R. 900.12(j), 900.22(g). The facility may request the Certifying Agency to review its determination that patient/physician notification is required.

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