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 experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices.
We can all make a difference to the process – REGULATORY DOCTOR
Listen to What the Patients Have to Say about a Contraceptive Medical Device Essure.
FDA Panel Meeting on September 24, 2015
Dr. Vikki Hufnagel Testimony on September 24, 2015
Last Updated: 2015-09-25
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