# In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/in-vitro-companion-diagnostic-devices-guidance-for-industry-and-food-and-drug-administration-staff/18915018-e22e-4930-90ea-2f601a510495 > FDA guidance document: In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff. Issue date: August 06, 2014. Get complete insights and analysis. --- ## Details - Title: In Vitro Companion Diagnostic Devices: 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: 2014-08-06 - Last Changed: 2020-03-02 - Docket Number: FDA-2011-D-0215 ## Related Documents - [Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/distribution-of-in-vitro-diagnostic-products-labeled-for-research-use-only-or-investigational-use-only-guidance-for-industry-and-fda-staff/dd8e1483-1883-474d-925f-8579c62a5379) - [Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/radio-frequency-wireless-technology-in-medical-devices-guidance-for-industry-and-fda-staff/a01cd2bb-faeb-44da-958b-c7ba3142c277) - [Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/adaptive-designs-for-medical-device-clinical-studies-guidance-for-industry-and-food-and-drug-administration-staff/70eec6c8-49d6-475b-8538-2f4e934cf72b)