Tag: Clinical Investigations

FDA Draft Guidance: Patient Engagement in Design and Conduct of Medical Device Clinical Investigations

The U.S. Food and Drug Administration (FDA) issued the draft guidance on September 23, 2019 on Patient Engagement in Design and Conduct of Medical Device Clinical Investigations.   The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients and their family caregivers. FDA believes that these individuals can and should […]

Follow this blog