Tag: FDA Advisory Meeting


Listen to What Patients Have to Say about Contraceptive Device Essure

The United States Food and Drug Administration (FDA) touts about “patient voice” or “patient preference” of  valuing the experience and perspectives of patients with devices as reflected in recent guidance entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.” FDA believes that patients can and should bring their own

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