Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation." This draft guidance provides FDA's proposed recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. This draft guidance is not final nor is it in effect at this time.