# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/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/e02081ea-4147-4909-8696-9b18ed3c269e

> FDA guidance document: 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. Issue date: September 15, 2017. Get complete insights and analysis.

---

## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2017-09-15
- Comment Close Date: 2015-11-12
- Last Changed: 2019-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2009-D-0386">FDA-2009-D-0386</a>

## 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](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-the-performance-characteristics-of-in-vitro-diagnostic-devices-for-the-detection-of-antibodies-to-borrelia-burgdorferi-guidance-for-industry-and-fda-staff/c9b388c4-7a07-4b67-9776-be87a6cfe611)
- [Assay Migration Studies for In Vitro Diagnostic Devices:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/assay-migration-studies-for-in-vitro-diagnostic-devices-guidance-for-industry-and-fda-staff/7800aabf-40dc-4ade-890e-83c1ec312a77)
- [Bundling Multiple Devices or Multiple Indications in a Single Submission:  Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/bundling-multiple-devices-or-multiple-indications-in-a-single-submission-guidance-for-industry-and-fda-staff/3a89ce6d-78fd-4b7d-9a46-1f67c0746805)
