Guidance Documents (Medical Devices and Radiation-Emitting Products) > Guidance for Industry and Food and Drug Administration Staff - 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 - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses

¹Document issued on: November 28, 2011
The draft of this document was issued on September 9. 2009.

For questions regarding this document contact Kate Simon, Ph.D., at (301)796-6204 or by email at kathleen.simon@fda.hhs.gov or Marina V. Kondratovich, Ph.D., at (301)796-6036 or by email at marina.kondratovich@fda.hhs.gov.
 U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Microbiology Devices

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to http://www.regulations.gov2/. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.

Table of Contents

1. Introduction
2. Background
3. Scope
4. Risks to Health
5. Establishing Performance Characteristics
   1. Analytical Studies
      • Limit of Detection
      • Within-Laboratory Precision/Repeatability
      • Reproducibility
      • Cross-Reactivity
      • Interference
      • Carry-Over and Cross-Contamination Studies (for devices with automated liquid handling systems)
      • Specimen Storage and Shipping Conditions
      • Reagent Storage and Shipping Conditions
   2. Clinical Performance Studies
      • Consideration of Guidelines
      • Intended Use
      • General study design considerations common to ASC-US triage and adjunct intended uses (and likely any other intended uses)
      • ASC-US Triage Claim – High Risk HPV Tests
      • ASC-US Population – HPV Genotyping Tests
      • Adjunct Claim – High Risk HPV Tests
      • Adjunct Claim – HPV Genotyping Tests
   3. Controls
      • External Controls
      • Internal Control
6. References
7. Statistical Analysis Appendix

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Guidance Documents (Medical Devices and Radiation-Emitting Products) > Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses