Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence." This draft guidance document describes FDA's proposed recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence. This draft guidance is not final nor is it in effect at this time.