Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 14, 2011
April 11, 2024
0d36538a-a98b-45b1-a9f0-96a4a8149a60
Related Documents
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentFebruary 14, 2013Center for Devices and Radiological Health
Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff
Guidance DocumentMarch 7, 2011Center for Devices and Radiological Health
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
Guidance DocumentMarch 27, 2013Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.