Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 15, 2017
April 11, 2019
e02081ea-4147-4909-8696-9b18ed3c269e
Related Documents
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
Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff
Guidance DocumentApril 25, 2013Center for Devices and Radiological Health
Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff
Guidance DocumentJune 22, 2007Center 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.